534
Views
9
CrossRef citations to date
0
Altmetric
Review Articles

Quinquennial Review of Progress in Degradation Studies and Impurity Profiling: An Instrumental Perspective Statistics

ORCID Icon, ORCID Icon &
Pages 226-253 | Published online: 21 May 2019

References

  • Zhang, K.; Pellett, J.-D.; Narang, A.-S.; Wang, Y.-J.; Zhang, Y.-T. Reactive Impurities in Large and Small Molecule Pharmaceutical Excipients – A Review. Trends Anal. Chem. 2018, 101, 34–42. DOI: 10.1016/j.trac.2017.11.003.
  • Mallikarjuna, S.; Ramalingam, P.; Sriram, P. Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Dosage Forms. J. Chromatogr. Sep. Tech. 2013, 04, 3–7. DOI: 10.4172/2157-7064.1000187.
  • Ambekar, A.; Kuchekar, B.-S. Application of a Validated Stability-Indicating HPTLC Method for Simultaneous Estimation of Paracetamol and Aceclofenac and Their Impurities. J. Chromatogr. Sep. Tech. 2016, 7, 1–10. DOI: 10.4172/2157-7064.1000324.
  • Siddiqui, M.-R.; Alothman, Z.-A.; Rahman, N. Analytical Techniques in Pharmaceutical Analysis: A Review. Arab. J. Chem. 2017, 10, S1409–S1421. DOI: 10.1016/j.arabjc.2013.04.016.
  • Patil, T.; Deshpande, A.; Deshpande, S. Critical Review on the Analytical Methods for the Estimation of Clofazimine in Bulk, Biological Fluids and Pharmaceutical Formulations. Crit. Rev. Anal. Chem. 2018, 8347, 1–11. DOI: 10.1080/10408347.2018.1451298.
  • Pajander, J.; Haugshøj, K.-B.; Bjørneboe, K.; Wahlberg, P.; Rantanen, J. Foreign Matter Identification from Solid Dosage Forms. J. Pharm. Biomed. Anal. 2013, 80, 116–125. DOI: 10.1016/j.jpba.2013.02.036.
  • Jain, A.; Sharma, S. Recent Trends in Impurity Profiling of Pharmaceutical Products. MIT Int. J. Pharm. Sci. 2017, 3, 1–6.
  • Li, N.; Yang, J.; Qin, F.; Li, F.; Gong, P. Isolation and Identification of a Major Impurity in a New Bulk Drug Candidate by Preparative LC, ESI-MSn, LC-MS-MS, and NMR. Chromatogr. J. Sci. 2007, 45, 45–49. DOI: 10.1093/chromsci/45.1.45.
  • Roberts, J.-K.; Smith, R.-J. Use of Liquid Chromatography-Nuclear Magnetic Resonance Spectroscopy for the Identiffication of Impurities in Drug Substances. Chromatogr. J. A 1994, 677, 385–389. DOI: 10.1016/0021-9673(94)80166-5.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Impurities in New Drug Substances Q3A (R2), 2006, 15.
  • International Conference on Harmonisation, Q3B (R2): Impurities in New Drug Products. ICH Harmonised Tripartite Guideline. 2006, 4, 1–12.
  • International Conference on Harmonisation, Q3C (R6): Impurities: Guideline for Residual Solvents. ICH Harmonised Guideline. 2016, 4, 1–34.
  • International Conference on Harmonisation, Q3D, Guideline for Elemental Impurities. ICH Harmonised Tripartite Guideline. 2014, 4, 1–73.
  • Singh, S.; Handa, T.; Narayanam, M.; Sahu, A.; Junwal, M.; Shah, R.-P. A Critical Review on the Use of Modern Sophisticated Hyphenated Tools in the Characterization of Impurities and Degradation Products. J. Pharm. Biomed. Anal. 2012, 69, 148–173. DOI: 10.1016/j.jpba.2012.03.044.
  • Guidance for Industry, Genotoxic and Carcinogenic, Impurities in Drug Substances and Products: Recommended Approaches, Draft guidance, FDA CDER. 2008, 1, 1–13.
  • Kang, S.-H.; Kwon, J.-Y.; Lee, J.-K.; Seo, Y.-R. Recent Advances in in Vivo Genotoxicity Testing: prediction of Carcinogenic Potential Using Comet and Micronucleus Assay in Animal Models. J. Cancer Prev. 2013, 18, 277–288. DOI: 10.15430/JCP.2013.18.4.277.
  • Li, N.; Yang, J.; Qin, F.; Li, F.; Gong, P. Isolation and Identification of a Major Impurity in a New Bulk Drug Candidate by Preparative LC, ESI-MSn, LC-MS-MS, and NMR. J. Chromatogr. Sci. 2007, 45, 45–49. DOI: 10.1093/chromsci/45.1.45.
  • Gupta, K. Analytical Quality by Design: A Mini Review. Biomed. J. Sci. Tech. Res. 2017, 1, 1–5. DOI: 10.26717/BJSTR.2017.01.000484.
  • Patil, T.; Deshpande, A. Development of an Innovative Quality by Design (QbD) Based Stability-Indicating HPLC Method and Its Validation for Clofazimine from Its Bulk and Pharmaceutical Dosage Forms. Chromatographia. 2018, 82, 1–12. DOI: 10.1007/s10337-018-3660-8.
  • Jain, D.; Basniwal, P.-K. Forced Degradation and Impurity Profiling: Recent Trends in Analytical Perspectives. J. Pharm. Biomed. Anal. 2013, 86, 11–35. DOI: 10.1016/j.jpba.2013.07.013.
  • Kurmi, M.; Singh, S. Stability Behavior of Antiretroviral Drugs and Their Combinations. 7: Comparative Degradation Pathways of Lamivudine and Emtricitabine and Explanation to Their Differential Degradation Behavior by Density Functional Theory. J. Pharm. Biomed. Anal 2017, 142, 155–161. DOI: 10.1016/j.jpba.2017.04.034.
  • Zhu, B.; Lu, Y.; Chen, L.; Yu, B.; Liu, Y.; Song, M.; Hang, T. Identification and Characterization of Related Substances in EVT-401 by Hyphenated LC–MS Techniques. J. Pharm. Anal, 2017, 7, 7223–7230. DOI: 10.1016/j.jpha.2017.03.008.
  • Kumar, N.; Devineni, S.-R.; Gajjala, P.-S.; Dubey, S.-K.; Kumar, P. Synthesis, Isolation, Identification and Characterization of New Process-Related Impurity in Isoproterenol Hydrochloride by HPLC, LC/ESI-MS and NMR. J. Pharm. Anal. 2017, 7, 394–400. DOI: 10.1016/j.jpha.2017.05.002.
  • Raju, C. K.; Pandey, A. K.; S, G.; Ghosh, K.; Pola, A.; Goud P, S. K.; Jaywant, M. A.; Navalgund, S. G. Isolation and Characterization of Novel Degradation Products of Doxofylline Using HPLC, FTIR, LCMS and NMR. J. Pharm. Biomed. Anal. 2017, 140, 1–10. DOI: 10.1016/j.jpba.2017.02.044.
  • Ruggenthaler, M.; Grass, J.; Schuh, W.; Huber, C.-G.; Reischl, R.-J. Levothyroxine Sodium Revisited: A Wholistic Structural Elucidation Approach of New Impurities via HPLC-HRMS/MS, on-Line H/D Exchange, NMR Spectroscopy and Chemical Synthesis. J. Pharm. Biomed. Anal. 2017, 135, 140–152. DOI: 10.1016/j.jpba.2016.12.002.
  • Gómez-Canela, C.; Bolivar-Subirats, G.; Tauler, R.; Lacorte, S. Powerful Combination of Analytical and Chemometric Methods for the Photodegradation of 5-Fluorouracil. J. Pharm. Biomed. Anal. 2017, 137, 33–41. DOI: 10.1016/j.jpba.2017.01.019.
  • Kumar, N.; Devineni, S.-R.; Dubey, S.-R.; Kumar, P. Potential Impurities of Anxiolytic Drug, Clobazam: Identification, Synthesis and Characterization Using HPLC, LC-ESI/MSn and NMR. J. Pharm. Biomed. Anal. 2017, 137, 268–278. DOI: 10.1016/j.jpba.2017.01.051.
  • Xia, K.; Shen, S.-S.; Gao, Q.; Shang, W.; Pan, Y.; Wu, J. Identification of a Novel Low-Level Impurity in Fungicide Pyraclostrobin by High-Performance Liquid Chromatography/Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2017, 138, 272–276. DOI: 10.1016/j.jpba.2017.02.027.
  • Zhu, P.; Lu, J.; Hong, L.; Su, W.; Van Schepdael, A.; Adams, E. Characterization of an Unknown Impurity in Doxofylline Using LC–MS and NMR. J. Pharm. Biomed. Anal. 2017, 140, 31–37. DOI: 10.1016/j.jpba.2017.03.025.
  • Yu, X.; Wang, F.; Li, J.; Shan, W.; Zhu, B.; Wang, J. Separation and Characterization of Unknown Impurities and Isomers in Flomoxef Sodium by LC-IT-TOF MS and Study of Their Negative-Ion Fragmentation Regularities. J. Pharm. Biomed. Anal. 2017, 140, 81–90. DOI: 10.1016/j.jpba.2017.03.032.
  • Lu, Y.; Shen, X.; Hang, T.; Song, M. Identification and Characterization of Process-Related Substances and Degradation Products in Apremilast: Process Optimization and Degradation Pathway Elucidation. J. Pharm. Biomed. Anal. 2017, 141, 70–78. DOI: 10.1016/j.jpba.2017.03.067.
  • Zhao, L.; Wang, Q.; Bie, Y.; Lu, X. Isolation, Identification and Characterization of Potential Impurities of Anidulafungin. J. Pharm. Biomed. Anal. 2017, 141, 192–199. DOI: 10.1016/j.jpba.2017.04.014.
  • Ruggenthaler, M.; Grass, J.; Schuh, W.; Huber, C.-G.; Reischl, R.-J. Impurity Profiling of liothyronine sodium by Means of Reversed Phase HPLC, High Resolution Mass Spectrometry, on-Line H/D Exchange and UV/Vis Absorption. J. Pharm. Biomed. Anal. 2017, 143, 147–158. DOI: 10.1016/j.jpba.2017.05.039.
  • Hu, Z.; Gao, S.; Gao, J. Investigation and Structural Elucidation of a New Impurity in Bulk Drug of Cilostazol by LC/MS/MS, FT-IR and NMR. J. Pharm. Biomed. Anal. 2017, 145, 16–23. DOI: 10.1016/j.jpba.2017.06.019.
  • Chahrour, O.; Malone, J.; Collins, M.; Salmon, V.; Greenan, C.; Bombardier, A.; Ma, Z.; Dunwoody, N. Development and Validation of an ICP-MS Method for the Determination of Elemental Impurities in TP-6076 Active Pharmaceutical Ingredient (API) according to USP 〈232〉/〈233〉. J. Pharm. Biomed. Anal. 2017, 145, 84–90. DOI: 10.1016/j.jpba.2017.06.045.
  • Zhang, X.; Li, J.; Wang, C.; Song, D.; Hu, C. Identification of Impurities in Macrolides by Liquid Chromatography–Mass Spectrometric Detection and Prediction of Retention Times of Impurities by Constructing Quantitative Structure–Retention Relationship (QSRR). J. Pharm. Biomed. Anal. 2017, 145, 262–272. DOI: 10.1016/j.jpba.2017.06.069.
  • Zhu, P.; Lu, J.; Wang, Z.; Su, W.; Chen, Y.; Schepdael, A.-V.; Adams, E. Characterization of Impurities in Sodium Cromoglycate Drug Substance and Eye Drops Using LC-ESI-Ion Trap MS and LC-ESI-QTOF MS. J. Pharm. Biomed. Anal. 2017, 145, 537–548. DOI: 10.1016/j.jpba.2017.07.015.
  • Xu, Y.; Wang, D.; Tang, L.; Wang, J. Separation and Characterization of Allergic Polymerized Impurities in Cephalosporins by 2D-HPSEC × LC-IT-TOF MS. J. Pharm. Biomed. Anal. 2017, 145, 742–750. DOI: 10.1016/j.jpba.2017.07.063.
  • Kurmi, M.; Sahu, A.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 5: Characterization of Novel Degradation Products of Abacavir Sulfate by Mass and Nuclear Magnetic Resonance Spectrometry. J. Pharm. Biomed. Anal. 2017, 134, 372–384. DOI: 10.1016/j.jpba.2016.10.019.
  • Raju, C.-K.; Pandey, A.-K.; Ghosh, K.; Pola, A.; Goud, S.-K.; Jaywant, M.-A.; Navalgund, S.-G.; Surendranath, K.-V. Isolation and Structural Characterization of Novel Photolytic Degradation Impurities of Deflazacort Using Q-TOF, 2D-NMR and FTIR. J. Pharm. Biomed. Anal. 2017, 133, 82–89. DOI: 10.1016/j.jpba.2016.11.005.
  • Vishnuvardhan, C.; Saibaba, B.; Allakonda, L.; Swain, D.; Gananadhamu, S.; Srinivas, R.; Satheeshkumar, N. LC–ESI–MS/MS Evaluation of Forced Degradation Behaviour of Silodosin: In Vitro anti Cancer Activity Evaluation of Silodosin and Major Degradation Products. J. Pharm. Biomed. Anal. 2017, 134, 1–10. DOI: 10.1016/j.jpba.2016.11.013.
  • Darcsi, A.; Rácz, A.; Béni, S. Identification and Characterization of a New Dapoxetine Impurity by NMR: Transformation of N-Oxide by Cope Elimination. J. Pharm. Biomed. Anal. 2017, 134, 187–194. DOI: 10.1016/j.jpba.2016.11.029.
  • Wu, X.; Zeng, X.; Wang, L.; Hang, T.; Song, M. Identification of Related Substances in Tofacitinib Citrate by LC-MS Techniques for Synthetic Process Optimization. J. Pharm. Biomed. Anal. 2017, 143, 17–25. DOI: 10.1016/j.jpba.2017.05.012.
  • Martano, C.; Ferretti, F.; Ghiani, S.; Buonsanti, F.; Bruno, E.; Lattuada, L.; Medana, C. Development and Validation of a New HPLC–MS Method for Meglumine Impurity Profiling. J. Pharm. Biomed. Anal. 2018, 149, 517–524. DOI: 10.1016/j.jpba.2017.11.039.
  • Pasquini, B.; Melani, F.; Caprini, C.; Del Bubba, M.; Pinzauti, S.; Orlandini, S.; Furlanetto, S. Combined Approach Using Capillary Electrophoresis, NMR and Molecular Modeling for Ambrisentan Related Substances Analysis: Investigation of Intermolecular Affinities, Complexation and Separation Mechanism. J. Pharm. Biomed. Anal. 2017, 144, 220–229. DOI: 10.1016/j.jpba.2017.01.038.
  • Assaf, J.; Gomes, D.-Z.; Wuest, B.; Parr, M.-K. Photostability Testing Using Online Reactor HPLC Hyphenation and Mass Spectrometric Compound Identification Illustrated by Ketoprofen as Model Compound. J. Pharm. Biomed. Anal. 2017, 145, 414–422. DOI: 10.1016/j.jpba.2017.07.006.
  • Wahl, O.; Cleynhens, J.; Verbruggen, A.-M.; Holzgrabe, U. Impurity Profiling of N,N′-ethylenebis-L-Cysteine Diethyl Ester (Bicisate). J. Pharm. Biomed. Anal. 2018, 150, 132–136. DOI: 10.1016/j.jpba.2017.11.078.
  • Yang, Y.; Lian, Y.; Zhong, P.; Wang, D.; Di, B.; Li, B. Characterization and Quantitative Analysis of Related Substances in Coenzyme a by HPLC and LC–MS/MS. J. Pharm. Biomed. Anal. 2018, 150, 220–232. DOI: 10.1016/j.jpba.2017.11.051.
  • Huang, Z.; Hu, Y.; Zha, Y.; Perrone, R.; Ruan, J.; Fish, W.-P. Determination of Polymeric Impurities in Asunaprevir Drug Substance and Product Using Size Exclusion Effect of Reversed-Phase Columns. J. Pharm. Biomed. Anal. 2018, 151, 200–208. DOI: 10.1016/j.jpba.2018.01.018.
  • Zhuang, T.; Zhang, W.; Cao, L.; He, K.; Wang, Y.; Li, J.; Chen, L.; Liu, B.; Zhang, G. Isolation, Identification and Characterization of Two Novel Process-Related Impurities in Olanzapine. J. Pharm. Biomed. Anal. 2018, 152, 188–196. DOI: 10.1016/j.jpba.2018.01.026.
  • Kurmi, M.; Patel, N.; Jhajra, S.; Bharatam, P.-V.; Singh, S. Characterization of Forced Degradation Products of Torasemide through MS Tools and Explanation of Unusual Losses Observed during Mass Fragmentation of Drug and Degradation Products through Density Functional Theory. J. Pharm. Biomed. Anal. 2017, 145, 209–218. DOI: 10.1016/j.jpba.2017.06.015.
  • Karpiuk, I.; Michalska, K.; Bus, K.; Kiljan, M.; Tyski, S. Identification and Determination of Related Substances of Ceftaroline Fosamil in Medicinal Product by High Performance Liquid Chromatography with Diode Array Detection and Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2017, 145, 651–660. DOI: 10.1016/j.jpba.2017.07.060.
  • Bellur Atici, E.; Yazar, Y.; Ağtaş, C.; Ridvanoğlu, N.; Karlığa, B. Development and Validation of Stability Indicating HPLC Methods for Related Substances and Assay Analyses of Amoxicillin and Potassium Clavulanate Mixtures. J. Pharm. Biomed. Anal. 2017, 136, 1–9. DOI: 10.1016/j.jpba.2016.12.032.
  • Vijayabaskar, S.; Mahalingam, V. Kalaivani, Analytical Method Development and Validation for the Analysis of Verapamil Hydrochloride and Its Related Substances by Using Ultra Perfomance Liquid Chromatography. J. Pharm. Biomed. Anal. 2017, 137, 189–195. DOI: 10.1016/j.jpba.2017.01.006.
  • Coelho, A.-S.; Chagas, C.-E.-P.; de Pádua, R.-M.; Pianetti, G.-A.; Fernandes, C. A Comprehensive Stability-Indicating HPLC Method for Determination of Chloroquine in Active Pharmaceutical Ingredient and Tablets: Identification of Oxidation Impurities. J. Pharm. Biomed. Anal. 2017, 145, 248–254. DOI: 10.1016/j.jpba.2017.06.023.
  • Aprile, S.; Canavesi, R.; Bianchi, M.; Grosa, G.; Del Grosso, E. Development and Validation of a Stability-Indicating HPLC-UV Method for the Determination of Thiocolchicoside and Its Degradation Products. J. Pharm. Biomed. Anal. 2017, 132, 66–71. DOI: 10.1016/j.jpba.2016.09.037.
  • Kumar, A.; Devineni, S.-R.; Dubey, S.-K.; Kumar, P.; Srivastava, V.; Ambulgekar, G.; Jain, M.; Gupta, D. K.; Singh, G.; Kumar, R.; et al. Identification Synthesis and Structural Characterization of Process Related and Degradation Impurities of Acrivastine and Validation of HPLC Method. J. Pharm. Biomed. Anal. 2017, 133, 15–26. DOI: 10.1016/j.jpba.2016.10.015.
  • Luo, Z.; Liu, A.; Liu, Y.; Wang, G.; Chen, X.; Wang, H.; Li, M.; Zhang, H.; Qiu, Y.; Zhai, H. Development of a Stability– Indicating HPLC Method for Simultaneous Determination of Ten Related Substances in Vonoprazan Fumarate Drug Substance. J. Pharm. Biomed. Anal. 2018, 149, 133–142. DOI: 10.1016/j.jpba.2017.11.011.
  • Dispas, A.; Desfontaine, V.; Andri, B.; Lebrun, P.; Kotoni, D.; Clarke, A.; Guillarme, D.; Hubert, P. Quantitative Determination of Salbutamol Sulfate Impurities Using Achiral Supercritical Fluid Chromatography. J. Pharm. Biomed. Anal. 2017, 134, 170–180. DOI: 10.1016/j.jpba.2016.11.039.
  • Mansour, M.-F.; Zhu, P.; Van Schepdael, A.; Adams, E. Development and Validation of a Liquid Chromatographic Method for the Analysis of Squaric Acid Dibutyl Ester and Its Impurities. J. Pharm. Biomed. Anal. 2017, 141, 165–172. DOI: 10.1016/j.jpba.2017.04.022.
  • Niedermeier, E.; Scriba, G.-K.-E. A Quality by Design-Based Approach to a Capillary Electrokinetic Assay for the Determination of Dextromepromazine and Levomepromazine Sulfoxide as Impurities of Levomepromazine. J. Pharm. Biomed. Anal. 2017, 146, 402–409. DOI: 10.1016/j.jpba.2017.09.003.
  • Devrukhakar, P.-S; Shiva Shankar, M.; Shankar, G.; Srinivas, R. A Stability Indicating HPLC Method of Zidovudine: validation, Characterization and Toxicity Prediction of Two Major Acid Degradation Products. J. Pharm. Anal., 2017, 7, 1–7. DOI: 10.1016/j.jpha.2017.01.006.
  • Kurmi, M.; Sahu, A.; Tiwari, S.-K.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 6: Evidence of Formation of Potentially Toxic Degradation Products of Zidovudine under Hydrolytic and Photolytic Conditions. RSC Adv. 2017, 7, 18803–18814. DOI: 10.1039/C7RA00678K.
  • Johnsirani, P.; Ch, V.; Lingesh, A.; Naidu, V.-G.-M.; Ch, N.; Satheeshkumar, N. Isolation, Characterization Using LC-ESI-QTOF, NMR and in Vitro Cytotoxicity Assay of Niclosamide Forced Degradation Products. J. Pharm. Biomed. Anal. 2017, 136, 148–155. DOI: 10.1016/j.jpba.2017.01.001.
  • Pinheiro, M.-S.; Viana, G.-M.; B. de, A.-A.; Vieira, A.-M.-T.; de Souza, C.-R.; Rodrigues, R.; Marins de, C.-E.-E.; Cabral, L.-M.; de Sousa, V.-P. Identification, Characterization and in Silico ADMET Prediction of Roflumilast Degradation Products. J. Pharm. Biomed. Anal. 2017, 138, 126–133. DOI: 10.1016/j.jpba.2017.02.012.
  • Lei, Y.; Jin, B.; Ma, C.; Zhang, T.; Li, T. Identification of Forced Degradation Products of Tedizolid Phosphate by Liquid Chromatography/Electrospray Ionization Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2017, 139, 221–231. DOI: 10.1016/j.jpba.2017.03.006.
  • Kryczyk, A.; Żmudzki, P.; Koczurkiewicz, P.; Piotrowska, J.; Pękala, E.; Hubicka, U. The Impact of ZnO and TiO2on the Stability of Clotrimazole under UVA Irradiation: Identification of Photocatalytic Degradation Products and in Vitro Cytotoxicity Assessment. J. Pharm. Biomed. Anal. 2017, 145, 283–292. DOI: 10.1016/j.jpba.2017.06.043.
  • Kurmi, M.; Sahu, A.; Singh, D.-K.; Singh, I.-P.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 8: Characterization and in-Silico Toxicity Prediction of Degradation Products of Efavirenz. J. Pharm. Biomed. Anal. 2018, 148, 170–181. DOI: 10.1016/j.jpba.2017.09.029.
  • Bhavani, G.; Krishna, B.-M.; Srinivasu, N.; Ramachandran, D.; Raman, V.-V.-S.-S.; Babu, H. Determination of Genotoxic Impurity in Atazanavir Sulphate Drug Substance by LC–MS. J. Pharm. Biomed. Anal. 2017, 132, 156–158. DOI: 10.1016/j.jpba.2016.09.025.
  • Jain, M.; Srivastava, V.; Kumar, R.; Dangi, V.; Hiriyanna, S.-G.; Kumar, A.; Kumar, P. Determination of Five Potential Genotoxic Impurities in Dalfampridine Using Liquid Chromatography. J. Pharm. Biomed. Anal. 2017, 133, 27–31. DOI: 10.1016/j.jpba.2016.10.013.
  • Grigori, K.; Loukas, Y.-L.; Malenović, A.; Samara, V.; Kalaskani, A.; Dimovasili, E.; Kalovidouri, M.; Dotsikas, Y. Chemometrically Assisted Development and Validation of LC–MS/MS Method for the Analysis of Potential Genotoxic Impurities in Meropenem Active Pharmaceutical Ingredient. J. Pharm. Biomed. Anal. 2017, 145, 307–314. DOI: 10.1016/j.jpba.2017.06.061.
  • Zacharis, C.-K.; Vastardi, E. Application of Analytical Quality by Design Principles for the Determination of Alkyl p-Toluenesulfonates Impurities in Aprepitant by HPLC. Validation Using Total-Error Concept. J. Pharm. Biomed. Anal. 2018, 150, 152–161. DOI: 10.1016/j.jpba.2017.12.009.
  • Iliou, K.; Malenović, A.; Loukas, Y.-L.; Dotsikas, Y. Analysis of Potential Genotoxic Impurities in Rabeprazole Active Pharmaceutical Ingredient via Liquid Chromatography-Tandem Mass Spectrometry, following Quality-by-Design Principles for Method Development. J. Pharm. Biomed. Anal. 2018, 149, 410–418. DOI: 10.1016/j.jpba.2017.11.037.
  • Kaushik, K.; Kaur, J.; Paul Kaur, V.; Saini, B.; Bansal, Y.; Bansal, G. Forced Degradation, LC-UV, MSnand LC-MS-TOF Studies on Azilsartan: Identification of a Known and Three New Degradation Impurities. J. Pharm. Biomed. Anal. 2016, 120, 202–211. DOI: 10.1016/j.jpba.2015.12.027.
  • Kumar, N.; Devineni, S.-R.; Gajjala, P.-R.; Gupta, D.-K.; Bhat, S.; Kumar, R.; Dubey, S.-K.; Kumar, P. Four Process-Related Potential New Impurities in Ticagrelor: Identification, Isolation, Characterization Using HPLC, LC/ESI-MS(n), NMR and Their Synthesis. J. Pharm. Biomed. Anal. 2016, 120, 248–260. DOI: 10.1016/j.jpba.2015.12.037.
  • Kumar, N.; Devineni, S.-R.; Singh, G.; Kadirappa, A.; Dubey, S.-K.; Kumar, P. Identification, Isolation and Characterization of Potential Process-Related Impurity and Its Degradation Product in Vildagliptin. J. Pharm. Biomed. Anal. 2016, 119, 114–121. DOI: 10.1016/j.jpba.2015.11.044.
  • Sastry, R.-V.-R.-P.; Venkatesan, C.-S.; Sastry, B.-S.; Mahesh, K. Identification and Characterization of Forced Degradation Products of Pralatrexate Injection by LC-PDA and LC–MS. J. Pharm. Biomed. Anal. 2016, 131, 400–409. DOI: 10.1016/j.jpba.2016.08.023.
  • Ye, Q.; Ding, W.; Rinaldi, F.; Huang, Y.; Miller, S.-A.; Bolgar, M. Structural Characterization of Low Level Degradants in Aztreonam Injection and an Innovative Approach to Aid HPLC Method Validation. J. Pharm. Biomed. Anal. 2016, 124, 358–364. DOI: 10.1016/j.jpba.2016.03.017.
  • Chadha, R.; Bali, A.; Bansal, G. Characterization of Stress Degradation Products of Duloxetine Hydrochloride Employing LC-UV/PDA and LC-MS/TOF Studies. J. Pharm. Biomed. Anal. 2016, 121, 39–55. DOI: 10.1016/j.jpba.2016.01.002.
  • Ragham, P.-K.; Chandrasekhar, K.-B. Development and Validation of a Stability-Indicating RP-HPL C-CAD Method for Gabapentin and Its Related Impurities in Presence of Degradation Products. J. Pharm. Biomed. Anal. 2016, 125, 122–129. DOI: 10.1016/j.jpba.2016.03.035.
  • Reddy, R.-B.; More, K.-R.; Jha, M.-S.; Sharma, B.; Magar, L. Identification, Synthesis, Isolation and Characterization of Formulation Related Impurity of Gabapentin. J. Pharm. Biomed. Anal. 2016, 129, 509–513. DOI: 10.1016/j.jpba.2016.07.035.
  • Kurmi, M.; Singh, D.-K.; Tiwari, S.; Sharma, P.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 3: Characterization of Interaction Products of Emtricitabine and Tenofovir Disoproxil Fumarate by Mass Spectrometry. J. Pharm. Biomed. Anal. 2016, 128, 438–446. DOI: 10.1016/j.jpba.2016.06.021.
  • Zhang, F.; Zhou, J.; Shi, Y.; Tavlarakis, P.; Karaisz, K. Mechanism Driven Structural Elucidation of Forced Degradation Products from Hydrocortisone in Solution. J. Pharm. Biomed. Anal. 2016, 128, 333–341. DOI: 10.1016/j.jpba.2016.06.004.
  • Chiguru, V.; Lingesh, A.; Srinivas, R.; Satheeshkumar, N. Forced Degradation Study of Racecadotril: Effect of Co-Solvent, Characterization of Degradation Products by UHPLC-Q-TOF-MS/MS, NMR and Cytotoxicity Assay. J. Pharm. Biomed. Anal. 2016, 128, 9–17. DOI: 10.1016/j.jpba.2016.05.008.
  • Liu, M.; Wang, J.; Liu, P. HPLC Method Development, Validation, and Impurity Characterization of a Potent Antitumor Nucleoside. T-dCyd (NSC 764276). J. Pharm. Biomed. Anal. 2016, 131, 429–435. DOI: 10.1016/j.jpba.2016.08.034.
  • Wingert, N.-R.; dos Santos, N.-O.; Nunes, M.-A.-G.; Gomes, P.; Müller, E.-I.; Flores, E.-M.-M.; Steppe, M. Characterization of Three Main Degradation Products from Novel Oral Anticoagulant Rivaroxaban under Stress Conditions by UPLC-Q-TOF-MS/MS. J. Pharm. Biomed. Anal. 2016, 123, 10–15. DOI: 10.1016/j.jpba.2016.01.053.
  • Ludvigsson, J-w.; Andersson, T.; Kjellberg, V. A New Method to Identify Hydrolytic Degradants in Drug Substances with UPLC-MS Using 18O-Labelled Water. J. Pharm. Biomed. Anal. 2016, 122, 9–15. DOI: 10.1016/j.jpba.2016.01.041.
  • Bērziņš, K.; Kons, A.; Grante, I.; Dzabijeva, D.; Nakurte, I.; Actiņš, A. Multi-Technique Approach for Qualitative and Quantitative Characterization of Furazidin Degradation Kinetics under Alkaline Conditions. J. Pharm. Biomed. Anal. 2016, 129, 433–440. DOI: 10.1016/j.jpba.2016.07.039.
  • Tian, J.; Rustum, A. Development and Validation of a Fast Static Headspace GC Method for Determination of Residual Solvents in Permethrin. J. Pharm. Biomed. Anal. 2016, 128, 408–415. DOI: 10.1016/j.jpba.2016.06.020.
  • Stepanovs, D.; Tetere, Z.; Rāviņa, I.; Kumpiņš, V.; Zicāne, D.; Bizdēna, Ē.; Bogans, J.; Novosjolova, I.; Grigaloviča, A.; Meri, R. M.; et al. Structural Characterization of Cevimeline and Its Trans-Impurity by Single Crystal XRD. J. Pharm. Biomed. Anal. 2016, 118, 404–409. DOI: 10.1016/j.jpba.2015.11.006.
  • Plachká, K.; Chrenková, L.; Douša, M.; Nováko, L. Development, Validation and Comparison of UHPSFC and UHPLC Methods for the Determination of Agomelatine and Its Impurities. J. Pharm. Biomed. Anal. 2016, 125, 376–384. DOI: 10.1016/j.jpba.2016.04.020.
  • Kurmi, M.; Kushwah, B.-S.; Sahu, A.; Narayanam, M.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 2: Characterization of Interaction Products of Lamivudine and Tenofovir Disoproxil Fumarate by Mass and NMR Spectrometry. J. Pharm. Biomed. Anal. 2016, 125, 245–259. DOI: 10.1016/j.jpba.2016.03.039.
  • Kühnreich, R.; Holzgrabe, U. Impurity Profiling of l-Methionine by HPLC on a Mixed Mode Column. J. Pharm. Biomed. Anal. 2016, 122, 118–125. DOI:10.1016/j.jpba.2016.01.057.
  • Omotani, H.; Yasuda, M.; Ishii, R.; Ikarashi, T.; Fukuuchi, T.; Yamaoka, N.; Mawatari, K.-I.; Kaneko, K.; Nakagomi, K. Analysis of l-DOPA-Derived Melanin and a Novel Degradation Product Formed under Alkaline Conditions. J. Pharm. Biomed. Anal. 2016, 125, 22–26. DOI: 10.1016/j.jpba.2016.03.019.
  • Reddy, R.-B.; More, K.-R.; Gupta, L.; Jha, M.-S.; Magar, L. Identification, Synthesis, Isolation and Characterization of New Impurity in Metoprolol Tartrate Tablets. J. Pharm. Biomed. Anal. 2016, 117, 104–108. DOI: 10.1016/j.jpba.2015.08.039.
  • Ma, X.; Zhou, W.; Zou, Q.; Ouyang, P. Structural Elucidation of the Impurities in Enzalutamide Bulk Drug and the Development, Validation of Corresponding HPLC Method. J. Pharm. Biomed. Anal. 2016, 131, 436–443. DOI: 10.1016/j.jpba.2016.08.036.
  • Xu, Q.; Tan, S.; Petrova, K. Development and Validation of a Hydrophilic Interaction Chromatography Method Coupled with a Charged Aerosol Detector for Quantitative Analysis of Nonchromophoric α-Hydroxyamines, Organic Impurities of Metoprolol. J. Pharm. Biomed. Anal. 2016, 118, 242–250. DOI: 10.1016/j.jpba.2015.11.002.
  • Zhang, H.; Sun, L.; Zou, L.; Hui, W.; Liu, L.; Zou, Q.; Ouyang, P. Identification, Characterization and HPLC Quantification of Process-Related Impurities in Trelagliptin Succinate Bulk Drug: Six Identified as New Compounds. J. Pharm. Biomed. Anal. 2016, 128, 18–27. DOI: 10.1016/j.jpba.2016.04.041.
  • Yang, Y.; Zhu, X.; Zhang, F.; Li, W.; Wu, Y.; Ding, L. Stability-Indicating HPLC Method Development and Structural Elucidation of Novel Degradation Products in Posaconazole Injection by LC-TOF/MS, LC-MS/MS and NMR. J. Pharm. Biomed. Anal. 2016, 125, 165–177. DOI: 10.1016/j.jpba.2016.03.034.
  • Reis, N.-F.-A.; de Assis, J.-C.; Fialho, S.-L.; Pianetti, G.-A.; Fernandes, C. Stability-Indicating UHPLC Method for Determination of Nevirapine in Its Bulk Form and Tablets: Identification of Impurities and Degradation Kinetic Study. J. Pharm. Biomed. Anal. 2016, 126, 103–108. DOI: 10.1016/j.jpba.2016.05.005.
  • Reddy, V.-B.; Yusop, Z.; Jaafar, J.; Aris, A.-B.; Majid, Z.-A.; Umar, K.; Talib, J. Development and Validation of a Selective, Sensitive and Stability Indicating UPLC-MS/MS Method for Rapid, Simultaneous Determination of Six Process Related Impurities in Darunavir Drug Substance. J. Pharm. Biomed. Anal. 2016, 128, 141–148. DOI: 10.1016/j.jpba.2016.05.026.
  • Runje, M.; Babić, S.; Meštrović, E.; Nekola, I.; Dujmić-Vučinić, Z.; Vojčić, N. Forced Degradation of Nepafenac: Development and Validation of Stability Indicating UHPLC Method. J. Pharm. Biomed. Anal. 2016, 123, 42–52. DOI: 10.1016/j.jpba.2016.02.003.
  • Jadhav, S.-B.; Kumar, C.-K.; Bandichhor, R.; Bhosale, P.-N. Development of RP UPLC-TOF/MS, Stability Indicating Method for Omeprazole and Its Related Substances by Applying Two Level Factorial Design; and Identification and Synthesis of Non-Pharmacopoeial Impurities. J. Pharm. Biomed. Anal. 2016, 118, 370–379. DOI: 10.1016/j.jpba.2015.10.005.
  • Terzić, J.; Popović, I.; Stajić, A.; Tumpa, A.; Jančić-Stojanovic, B. Application of Analytical Quality by Design Concept for Bilastine and Its Degradation Impurities Determination by Hydrophilic Interaction Liquid Chromatographic Method. J. Pharm. Biomed. Anal. 2016, 125, 385–393. DOI: 10.1016/j.jpba.2016.04.022.
  • Maksić, J.; Tumpa, A.; Stajić, A.; Jovanović, M.; Rakić, T.; Jancic-Stojanovic, B. Hydrophilic Interaction Liquid Chromatography in Analysis of Granisetron HCl and Its Related Substances. Retention Mechanisms and Method Development. J. Pharm. Biomed. Anal. 2016, 123, 93–103. DOI: 10.1016/j.jpba.2016.02.010.
  • Swain, D.; Samanthula, G.; Bhagat, S.; Bharatam, P.-V.; Akula, P.-V.; Sinha, B.-N. Characterization of Forced Degradation Products and in Silico Toxicity Prediction of Sofosbuvir: A Novel HCV NS5B Polymerase Inhibitor. J. Pharm. Biomed. Anal. 2016, 116, 352–363. DOI: 10.1016/j.jpba.2015.12.045.
  • Gričar, M.; Andrenšek, S. Determination of Azide Impurity in Sartans Using Reversed-Phase HPLC with UV Detection. J. Pharm. Biomed. Anal. 2016, 125, 27–32. DOI: 10.1016/j.jpba.2016.03.020.
  • Wang, J.; Yang, S.; Zhang, K. A Simple and Sensitive Method to Analyze Genotoxic Impurity Hydrazine in Pharmaceutical Materials. J. Pharm. Biomed. Anal. 2016, 126, 141–147. DOI: 10.1016/j.jpba.2016.04.038.
  • Kumar Pandey, A.; Rapolu, R.; Raju, C.-K.; Sasalamari, G.; Kumar, G.-S.; Awasthi, A.; Navalgund, S.-G.; Surendranath, K.-V. The Novel Acid Degradation Products of Losartan: Isolation and Characterization Using Q-TOF, 2D-NMR and FTIR. J. Pharm. Biomed. Anal. 2016, 120, 65–71. DOI: 10.1016/j.jpba.2015.11.037.
  • Santos, M.; García, L.-C.; Checura, C.; Donadío, L.-G.; Fernandez, C.; Orgueira, H.; Comin, M.-J. Synthesis and Characterization of New Related Substances of the Antiarrhythmic Drug Dronedarone Hydrochloride. J. Pharm. Biomed. Anal. 2015, 114, 441–446. DOI: 10.1016/j.jpba.2015.06.026.
  • Oh, H.-A.; Kim, D.; Lee, S.-H.; Jung, B.-H. Simultaneous Quantitative Determination of Celecoxib and Its Two Metabolites Using Liquid Chromatography-Tandem Mass Spectrometry in Alternating Polarity Switching Mod. J. Pharm. Biomed. Anal. 2015, 107, 32–39. DOI: 10.1016/j.jpba.2014.12.004.
  • Wahl, O.; Holzgrabe, U. Impurity Profiling of Ibandronate Sodium by HPLC-CAD. J. Pharm. Biomed. Anal. 2015, 144, 254–264. DOI: 10.1016/j.jpba.2015.06.002.
  • Pantović, J.; Malenović, A.; Vemić, A.; Kostić, N.; Medenica, M. Development of Liquid Chromatographic Method for the Analysis of Dabigatran Etexilate Mesilate and Its Ten Impurities Supported by Quality-by-Design Methodology. J. Pharm. Biomed. Anal. 2015, 111, 7–13. DOI: 10.1016/j.jpba.2015.03.009.
  • Zhu, P.; Yang, W.; Hong, L.; Cheng, Q.; Luo, L.; He, J.; Chen, J. Characterization of a Novel Process-Related Impurity in Commercial Bendazac Lysine Eye Drops by LC–ESI-QTOF/MS/MS and NMR. J. Pharm. Biomed. Anal. 2015, 107, 437–443. DOI: 10.1016/j.jpba.2015.01.002.
  • Narayanam, M.; Sahu, A.; Singh, S. Use of LC-MS/TOF, LC-MSn, NMR and LC-NMR in Characterization of Stress Degradation Products: Application to Cilazapril. J. Pharm. Biomed. Anal. 2015, 111, 190–203. DOI: 10.1016/j.jpba.2015.03.038.
  • Chadha, R.; Bali, A.; Bansal, G. Identification and Characterization of Stress Degradation Products of Dronedarone Hydrochloride Employing LC-UV/PDA, LC–MS/TOF and MSn Studies. J. Pharm. Biomed. Anal. 2016, 110, 139–148. DOI: 10.1016/j.jpba.2015.10.028.
  • Stypulkowska, K.; Blazewicz, A.; Brudzikowska, A.; Warowna-Grzeskiewicz, M.; Sarna, K.; Fijalek, Z. Development of High Performance Liquid Chromatography Methods with Charged Aerosol Detection for the Determination of Lincomycin, Spectinomycin and Its Impurities in Pharmaceutical Products. J. Pharm. Biomed. Anal. 2015, 112, 8–14. DOI: 10.1016/j.jpba.2015.03.030.
  • Wang, D.; Wang, F.; Wang, J. Characterization of the Impurities and Isomers in Cefetamet Pivoxil Hydrochloride by Liquid Chromatography/Time-of-Flight Mass Spectrometry and Ion Trap Mass Spectrometry. J. Pharm. Biomed. Anal. 2015, 113, 71–77. DOI: 10.1016/j.jpba.2015.03.013.
  • Li, P.; Wang, L.; Song, M.; Hang, T. Identification and Characterization of Related Substances in Pomalidomide by Hyphenated LC-MS Techniques. J. Pharm. Biomed. Anal. 2015, 114, 159–167. DOI: 10.1016/j.jpba.2015.05.018.
  • Patel, P.-N.; Kalariya, P.-D.; Gananadhamu, S.; Srinivas, R. Forced Degradation of Fingolimod: Effect of co-Solvent and Characterization of Degradation Products by UHPLC-Q-TOF-MS/MS and 1H NMR. J. Pharm. Biomed. Anal. 2015, 115, 388–394. DOI: 10.1016/j.jpba.2015.07.028.
  • Zalewski, P.; Skibiński, R.; Talaczyńska, A.; Paczkowska, M.; Garbacki, P.; Cielecka-Piontek, J. Stability Studies of Cefoselis Sulfate in the Solid State. J. Pharm. Biomed. Anal. 2015, 115, 222–226. DOI: 10.1016/j.jpba.2015.05.031.
  • Abdelaleem, E.-A.; Naguib, I.-A.; Hassan, E.-S.; Ali, N.-W. HPTLC and RP-HPLC Methods for Simultaneous Determination of Paracetamol and Pamabrom in Presence of Their Potential Impurities. J. Pharm. Biomed. Anal. 2015, 116, 22–27. DOI: 10.1016/j.jpba.2015.04.030.
  • Li, W.; Wang, J.; Yan, Z.-Y. Development of a Sensitive and Rapid Method for Rifampicin Impurity Analysis Using Supercritical Fluid Chromatography. J. Pharm. Biomed. Anal. 2015, 114, 341–347. DOI: 10.1016/j.jpba.2015.06.012.
  • Galea, C.; Mangelings, D.; Vander, H.-Y. Method Development for Impurity Profiling in SFC: The Selection of a Dissimilar Set of Stationary Phases. J. Pharm. Biomed. Anal. 2015, 111, 333–343. DOI: 10.1016/j.jpba.2014.12.043.
  • Liu, L.; Cao, N.; Ma, X.; Xiong, K.; Sun, L.; Zou, Q.; Yao, L. Stability-Indicating Reversed-Phase HPLC Method Development and Characterization of Impurities in Vortioxetine Utilizing LC-MS, IR and NMR. J. Pharm. Biomed. Anal. 2016, 116, 325–332. DOI: 10.1016/j.jpba.2015.08.028.
  • Vojta, J.; Jedlička, A.; Coufal, P.; Janečková, L. A New, Rapid, Stability-Indicating UPLC Method for Separation and Determination of Impurities in Amlodipine Besylate, Valsartan and Hydrochlorothiazide in Their Combined Tablet Dosage Form. J. Pharm. Biomed. Anal. 2015, 116, 36–44. DOI: 10.1016/j.jpba.2015.01.059.
  • Peterka, T.-R.; Grahek, R.; Hren, J.; Bastarda, A.; Bergles, J.; Urleb, U. Solid State Compatibility Study and Characterization of a Novel Degradation Product of Tacrolimus in Formulation. J. Pharm. Biomed. Anal. 2015, 110, 67–75. DOI: 10.1016/j.jpba.2015.02.28.
  • Fanigliulo, A.; De Filippis, P.; Curcuruto, O.; Repeto, P.; Roveda, D.; Hartenstein, M.; Adams, E.; Cabooter, D. Development and Validation of a Stability Indicating Method for S-Carboxymethyl-l-Cysteine and Related Degradation Products in Oral Syrup Formulation. J. Pharm. Biomed. Anal. 2015, 115, 39–47. DOI: 10.1016/j.jpba.2015.06.031.
  • Zhang, D.; Su, J. Investigation of Reduction Process and Related Impurities in Ezetimibe. J. Pharm. Biomed. Anal. 2015, 107, 355–363. DOI: 10.1016/j.jpba.2015.01.008.
  • Jovanović, M.; Rakić, T.; Tumpa, A.; Jančić Stojanović, B. Quality by Design Approach in the Development of Hydrophilic Interaction Liquid Chromatographic Method for the Analysis of Iohexol and Its Impurities. J. Pharm. Biomed. Anal. 2015, 111, 42–48. DOI: 10.1016/j.jpba.2015.02.28.
  • Boussès, C.; Ferey, L.; Vedrines, E.; Gaudin, K. Using an Innovative Combination of Quality-by-Design and Green Analytical Chemistry Approaches for the Development of a Stability Indicating UHPLC Method in Pharmaceutical Products. J. Pharm. Biomed. Anal. 2015, 115, 114–122. DOI: 10.1016/j.jpba.2015.07.003.
  • Rapolu, R.; Pandey, A.-K.; Raju, C.-K.; Ghosh, K.; Srinivas, K.; Awasthi, A.; Navalgund, S.-G.; Surendranath, K.-V. A Novel UV Degradation Product of Ebastine: Isolation and Characterization Using Q-TOF, NMR, IR and Computational Chemistry. J. Pharm. Biomed. Anal. 2015, 107, 488–494. DOI: 10.1016/j.jpba.2015.01.039.
  • Ramesh, T.; Nageswara Rao, P.; Nageswara Rao, R. LC-MS/MS Characterization of Forced Degradation Products of Zofenopril. J. Pharm. Biomed. Anal. 2014, 88, 609–616. DOI: 10.1016/j.jpba.2013.10.018.
  • Rao, R.-N.; Ramachandra, B.; Sravan, B.; Khalid, S. LC-MS/MS Structural Characterization of Stress Degradation Products Including the Development of a Stability Indicating Assay of Darunavir: An anti-HIV Drug. J. Pharm. Biomed. Anal. 2014, 89, 28–33. DOI: 10.1016/j.jpba.2013.10.007.
  • Zhang, D.; Song, X.; Su, J. Isolation, Identification and Characterization of Novel Process-Related Impurities in Flupirtine Maleate. J. Pharm. Biomed. Anal. 2014, 90, 27–34. DOI: 10.1016/j.jpba.2013.11.015.
  • Regalado, E.-L.; Dermenjian, R.-K.; Joyce, L.-A.; Welch, C.-J. Detection of Dehalogenation Impurities in Organohalogenated Pharmaceuticals by UHPLC-DAD-HRESIMS. J. Pharm. Biomed. Anal. 2014, 90, 1–5. DOI: 10.1016/j.jpba.2013.12.043.
  • Gana, I.; Dugay, A.; Henriet, T.; Rietveld, I.-B.; Bernard, M.; Guechot, C.; Teulon, J.-M.; Safta, F.; Yagoubi, N.; Céolin, R.; Do, B. Degradation Pathways Study of the Natriuretic and β-Adrenoceptor Antagonist Tienoxolol Using Liquid Chromatography-Electrospray Ionization Multistage Mass Spectrometry. J. Pharm. Biomed. Anal. 2014, 89, 58–67. DOI: 10.1016/j.jpba.2014.03.016.
  • Handa, T.; Singh, S.; Singh, I.-P. Characterization of a New Degradation Product of Nifedipine Formed on Catalysis by Atenolol: A Typical Case of Alteration of Degradation Pathway of One Drug by Another. J. Pharm. Biomed. Anal. 2014, 89, 6–17. DOI: 10.1016/j.jpba.2013.10.024.
  • Prakash, L.; Himaja, M.; Subbaiah, B.-V.; Vasudev, R.; Srinivasulu, C.; Haribabu, R. Isolation, Identification and Characterization of Degradant Impurities in Tolterodine Tartrate Formulation. J. Pharm. Biomed. Anal. 2014, 90, 215–221. DOI: 10.1016/j.jpba.2013.12.007.
  • Bourezg, Z.; Cartiser, N.; Ettouati, L.; Guillon, J.; Lacoudre, A.; Pinaud, N.; Le Borgne, M.; Fessi, H. Structural Elucidation of Two Photolytic Degradation Products of Tetrabenazine. J. Pharm. Biomed. Anal. 2014, 89, 138–143. DOI: 10.1016/j.jpba.2013.12.032.
  • Douša, M.; Srbek, J.; Rádl, S.; Černý, J.; Klecán, O.; Havlíček, J.; Tkadlecová, M.; Pekárek, T.; Gibala, P.; Nováková, L. Identification, Characterization, Synthesis and HPLC Quantification of New Process-Related Impurities and Degradation Products in Retigabine. J. Pharm. Biomed. Anal. 2014, 94, 71–76. DOI: 10.1016/j.jpba.2014.01.042.
  • Vojta, J.; Hanzlík, P.; Jedlička, A.; Coufal, P. Separation and Determination of Impurities in Paracetamol, Codeine and Pitophenone in the Presence of Fenpiverinium in Combined Suppository Dosage Form. J. Pharm. Biomed. Anal. 2015, 102, 85–92. DOI: 10.1016/j.jpba.2014.09.002.
  • Wahl, O.; Holzgrabe, U. Impurity Profiling of Carbocisteine by HPLC-CAD, qNMR and UV/Vis Spectroscopy. J. Pharm. Biomed. Anal. 2014, 90, 1–10. DOI: 10.1016/j.jpba.2014.02.012.
  • Anandgaonkar, V.; Gupta, A.; Kona, S.; Talluri, M.-V.-N.-K. Isolation, LC-MS/MS and 2D-NMR Characterization of Alkaline Degradants of Tenofovir Disoproxil Fumarate. J. Pharm. Biomed. Anal. 2015, 107, 175–185. DOI: 10.1016/j.jpba.2014.12.034.
  • Kumar Talluri, M.-V.-N.; Dharavath, S.; Kalariya, P.-D.; Prasanth, B.; Srinivas, R. Structural Characterization of Alkaline and Oxidative Stressed Degradation Products of Lurasidone Using LC/ESI/QTOF/MS/MS. J. Pharm. Biomed. Anal. 2015, 105, 1–9. DOI: 10.1016/j.jpba.2014.11.035.
  • Panyala, N.-R.; Sturzbecher-Hoehne, M.; Abergel, R.-J. Identification of Process Related Trace Level Impurities in the Actinide Decorporation Agent 3,4,3-LI(1,2-HOPO): Nozzle-Skimmer Fragmentation via ESI LC-QTOFMS. J. Pharm. Biomed. Anal. 2014, 100, 157–166. DOI: 10.1016/j.jpba.2014.08.004.
  • Liu, M.; Wang, J.; Wu, X.; Wang, E.; Baptista, D.; Scott, B.; Liu, P. HPLC Method Development, Validation and Impurity Characterization for an Antitumor Hsp90 inhibitor-PU-H71 (NSC 750424). J. Pharm. Biomed. Anal. 2014, 89, 34–41. DOI: 10.1016/j.jpba.2013.10.021.
  • Rapolu, R.; Raju, C.-K.; Srinivas, K.; Awasthi, A.; Navalgund, S.-G.; Surendranath, K.-V. Isolation and Characterization of a Novel Acid Degradation Impurity of Amlodipine Besylate Using Q-TOF, NMR, IR and Single Crystal X-Ray. J. Pharm. Biomed. Anal. 2014, 99, 59–66. DOI: 10.1016/j.jpba.2014.07.006.
  • Darcsi, A.; Tóth, G.; Kökösi, J.; Béni, S. Structure Elucidation of a Process-Related Impurity of Dapoxetine. J. Pharm. Biomed. Anal. 2014, 96, 272–277. DOI: 10.1016/j.jpba.2014.04.002.
  • Wang, Y.; Zhang, Z.; Wu, L.; Zhang, X.; Wang, H.; Ye, W.; Li, P. Isolation and Structure Characterization of Related Impurities in Etimicin Intermediate P1 by LC/ESI-MSnand NMR. J. Pharm. Biomed. Anal. 2014, 97, 97–102. DOI: 10.1016/j.jpba.2014.04.024.
  • Quirk, E.; Doggett, A.; Bretnall, A. Determination of Residual Acetone and Acetone Related Impurities in Drug Product Intermediates Prepared as Spray Dried Dispersions (SDD) Using Gas Chromatography with Headspace Autosampling (GCHS). J. Pharm. Biomed. Anal. 2014, 96, 37–44. DOI: 10.1016/j.jpba.2014.03.027.
  • Marley, A.; Stalcup, A. M.; Connolly, D. Development and Validation of a New Stability Indicating Reversed Phase Liquid Chromatographic Method for the Determination of Prednisolone Acetate and Impurities in an Ophthalmic Suspension. J. Pharm. Biomed. Anal. 2015, 102, 261–266. DOI: 10.1016/j.jpba.2014.09.023.
  • Venugopal, N.; Vijaya Bhaskar Reddy, A.; Madhavi, G. Development and Validation of a Systematic UPLC-MS/MS Method for Simultaneous Determination of Three Phenol Impurities in Ritonavir. J. Pharm. Biomed. Anal. 2014, 90, 127–133. DOI: 10.1016/j.jpba.2013.11.029.
  • Zalewski, P.; Skibiński, R.; Cielecka-Piontek, J. Stability Studies of Cefpirome Sulfate in the Solid State: Identification of Degradation Products. J. Pharm. Biomed. Anal. 2014, 92, 22–25. DOI: 10.1016/j.jpba.2013.12.039.
  • Narayanam, M.; Singh, S. Characterization of Stress Degradation Products of Fosinopril by Using LC-MS/TOF, MSnand on-Line H/D Exchange. J. Pharm. Biomed. Anal. 2014, 92, 135–143. DOI: 10.1016/j.jpba.2014.01.010.
  • Ramisetti, N.-R.; Kuntamukkala, R.; Lakshetti, S.; Sripadi, P. Identification and Characterization of Stress Degradants of Lacosamide by LC-MS and ESI-Q-TOF-MS/MS: Development and Validation of a Stability Indicating RP-HPLC Method. J. Pharm. Biomed. Anal. 2014, 95, 256–264. DOI: 10.1016/j.jpba.2014.03.010.
  • Byrne, J.; Velasco-Torrijos, T.; Reinhardt, R. Development and Validation of a Novel Stability-Indicating HPLC Method for the Simultaneous Assay of Betamethasone-17-Valerate, Fusidic Acid, Potassium Sorbate, Methylparaben and Propylparaben in a Topical Cream Preparation. J. Pharm. Biomed. Anal. 2014, 96, 111–117. DOI: 10.1016/j.jpba.2014.03.005.
  • Djabrouhou, N.; Guermouche, M.-H. Development of a Stability-Indicating HPLC Method of Etifoxine with Characterization of Degradation Products by LC-MS/TOF, 1H and 13C NMR. J. Pharm. Biomed. Anal. 2014, 100, 11–20. DOI: 10.1016/j.jpba.2014.07.017.
  • Wu, C.; Xu, X.; Feng, C.; Shi, Y.; Liu, W.; Zhu, X.; Zhang, J. Degradation Kinetics Study of Cabozantinib by a Novel Stability-Indicating LC Method and Identification of Its Major Degradation Products by LC/TOF-MS and LC-MS/MS. J. Pharm. Biomed. Anal. 2014, 98, 356–363. DOI: 10.1016/j.jpba.2014.06.008.
  • Canavesi, R.; Aprile, S.; Varese, E.; Grosa, G. Development and Validation of a Stability-Indicating LC-UV Method for the Determination of Pantethine and Its Degradation Product Based on a Forced Degradation Study. J. Pharm. Biomed. Anal. 2014, 97, 141–150. DOI: 10.1016/j.jpba.2014.04.025.
  • Hassane, S.-Y.; Secrétan, P.-H.; Henriet, T.; Bernard, M.; Amrani, F.; Akrout, W.; Tilleul, P.; Yagoubi, N.; Do, B. Identification of the Major Degradation Pathways of Ticagrelor. J. Pharm. Biomed. Anal. 2015, 105, 74–83. DOI: 10.1016/j.jpba.2014.11.046.
  • Kurmi, M.; Kumar, S.; Singh, B.; Singh, S. Implementation of Design of Experiments for Optimization of Forced Degradation Conditions and Development of a Stability-Indicating Method for Furosemide. J. Pharm. Biomed. Anal. 2014, 96, 135–143. DOI: 10.1016/j.jpba.2014.03.035.
  • Karmarkar, S.; Yang, X.; Garber, R.; Szajkovics, A.; Koberda, M. Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance. J. Pharm. Biomed. Anal. 2014, 100, 167–174. DOI: 10.1016/j.jpba.2014.07.002.
  • Vemić, A.; Rakić, T.; Malenović, A.; Medenica, M. Chaotropic Salts in Liquid Chromatographic Method Development for the Determination of Pramipexole and Its Impurities following Quality-by-Design Principles. J. Pharm. Biomed. Anal. 2015, 102, 314–320. DOI: 10.1016/j.jpba.2014.09.031.
  • Fu, M.; Lu, Q.; Hewitt, E.; Wang, J. Ultra High Performance Liquid Chromatography Coupled with High Resolution Quantitation Mass Spectrometry Method Development and Validation for Determining Genotoxic 2,5-Dichlorobenzoyl Chloride in MLN9708 Drug Substance. J. Pharm. Biomed. Anal. 2014, 89, 233–239. DOI: 10.1016/j.jpba.2013.11.012.
  • Raman, N.-V.-V.-S.-S.; Prasad, A.-V.-S.-S.; Reddy, K.-R. Sensitive Derivatization Methods for the Determination of Genotoxic Impurities in Drug Substances Using Hyphenated Techniques. J. Pharm. Biomed. Anal. 2014, 89, 276–281. DOI: 10.1016/j.jpba.2013.11.013.
  • Zhang, H.; Wilson, J.; Zhang, J.; Luo, Y. Characterization of Potential Degradation Products in a PEGylating Reagent 20kDa Monomethoxy Polyethylene Glycol Propionaldehyde by RP-HPLC, APCI-MS and NMR. J. Pharm. Biomed. Anal. 2014, 89, 221–226. DOI: 10.1016/j.jpba.2013.10.046.
  • Doomkaew, A.; Prutthiwanasan, B.; Suntornsuk, L. Stability Indicating MEKC Method for the Determination of Gliclazide and Its Specified Impurities. J. Pharm. Biomed. Anal. 2015, 102, 119–128. DOI: 10.1016/j.jpba.2014.08.032.
  • Kahsay, G.; Shraim, F.; Villatte, P.; Rotger, J.; Cassus-Coussère, C.; Van Schepdael, A.; Hoogmartens, J.; Adams, E. Development and Validation of a Reversed Phase Liquid Chromatographic Method for Analysis of Oxytetracycline and Related Impurities. J. Pharm. Biomed. Anal. 2013, 75, 199–206. DOI: 10.1016/j.jpba.2012.11.042.
  • Jedynak, Ł.; Puchalska, M.; Zezula, M.; Łaszcz, M.; Łuniewski, W.; Zagrodzka, J. Stability of Sample Solution as a Crucial Point during HPLC Determination of Chemical Purity of Temozolomide Drug Substance. J. Pharm. Biomed. Anal. 2013, 83, 19–27. DOI: 10.1016/j.jpba.2013.04.032.
  • Doddaga, S.; Peddakonda, R. Chloroquine-N-Oxide, a Major Oxidative Degradation Product of Chloroquine: Identification, Synthesis and Characterization. J. Pharm. Biomed. Anal. 2013, 81–82, 118–125. DOI: 10.1016/j.jpba.2013.04.004.
  • Van den Bossche, L.; Daidone, F.; Van Schepdael, A.; Hoogmartens, J.; Adams, E. Characterization of Impurities in Josamycin Using Dual Liquid Chromatography Combined with Mass Spectrometry. J. Pharm. Biomed. Anal. 2013, 73, 66–76. DOI: 10.1016/j.jpba.2012.01.012.
  • Liu, Y.; Chen, L.; Ji, Y. Quantification and Structural Elucidation of Potential Impurities in Agomelatine Active Pharmaceutical Ingredient. J. Pharm. Biomed. Anal. 2013, 81–82, 193–201. DOI: 10.1016/j.jpba.2013.04.016.
  • Yamamoto, E.; Niijima, J.; Asakawa, N. Selective Determination of Potential Impurities in an Active Pharmaceutical Ingredient Using HPLC-SPE-HPLC. J. Pharm. Biomed. Anal. 2013, 84, 41–47. DOI: 10.1016/j.jpba.2013.05.033.
  • Alexander, A.-J.; Zhang, L.; Hooker, T.-F.; Tomasella, F.-P. Comparison of Supercritical Fluid Chromatography and Reverse Phase Liquid Chromatography for the Impurity Profiling of the Antiretroviral Drugs Lamivudine/BMS-986001/Efavirenz in a Combination Tablet. J. Pharm. Biomed. Anal. 2013, 78–79, 243–251. DOI: 10.1016/j.jpba.2013.02.019.
  • Respaud, R.; Quenum, L.; Plichon, C.; Tournamille, J.-F.; Gyan, E.; Antier, D.; Viaud-Massuard, M.-C. A Stability-Indicating, Ion-Pairing, Reversed-Phase Liquid Chromatography Method for Studies of Daunorubicin Degradation in i.v. infusion Fluids. J. Pharm. Biomed. Anal. 2013, 83, 164–170. DOI: 10.1016/j.jpba.2013.05.007.
  • Guntupalli, S.; Ray, U.-K.; Murali, N.; Gupta, P.-B.; Kumar, V.-J.; Satheesh, D.; Islam, A. Identification, Isolation and Characterization of Process Related Impurities in Ezetimibe. J. Pharm. Biomed. Anal. 2014, 88, 385–390. DOI: 10.1016/j.jpba.2013.09.020.
  • Yuan, Y.-Z.; Zhao, X.; Zhang, M.; Fan, X.-L.; Hu, C.-Q.; Jin, S.-H.; Van Schepdael, A.; Hoogmartens, J.; Adams, E. Impurity Profiling of Micronomicin Sulfate Injection by Liquid Chromatography-Ion Trap Mass Spectrometry. J. Pharm. Biomed. Anal. 2013, 75, 94–104. DOI: 10.1016/j.jpba.2012.11.029.
  • Nageswara Rao, R.; Ramachandra, B.; Santhakumar, K. RP-HPLC Separation and Characterization of Unknown Impurities of a Novel HIV-Protease Inhibitor Darunavir by ESI-MS and 2D NMR Spectroscopy. J. Pharm. Biomed. Anal. 2013, 75, 186–191. DOI: 10.1016/j.jpba.2012.10.022.
  • Jamrógiewicz, M.; Wielgomas, B. Detection of Some Volatile Degradation Products Released during Photoexposition of Ranitidine in a Solid State. J. Pharm. Biomed. Anal. 2013, 76, 177–182. DOI: 10.1016/j.jpba.2012.12.019.
  • Nageswara Rao, R.; Ramakrishna, K.; Sravan, B.; Santhakumar, K. RP-HPLC Separation and ESI-MS, 1H, and 13C NMR Characterization of Forced Degradants Including Process Related Impurities of Carisbamate: Method Development and Validation. J. Pharm. Biomed. Anal. 2013, 77, 49–54. DOI: 10.1016/j.jpba.2013.01.001.
  • Nageswara Rao, R.; Naidu, C.-G.; Prasad, K.-G.; Santhakumar, B.; Saida, S. Development and Validation of a Stability Indicating Assay of Doxofylline by RP-HPLC: ESI-MS/MS, 1H and 13C NMR Spectroscopic Characterization of Degradation Products and Process Related Impurities. J. Pharm. Biomed. Anal. 2013, 78–79, 92–99. DOI: 10.1016/j.jpba.2013.02.004.
  • Béni, Z.; Háda, V.; Varga, E.; Mahó, S.; Aranyi, A.; Szántay, C. New Oxidative Decomposition Mechanism of Estradiol through the Structural Characterization of a Minute Impurity and Its Degradants. J. Pharm. Biomed. Anal. 2013, 78–79, 183–189. DOI: 10.1016/j.jpba.2013.02.015.
  • Elkins, P.; Coleman, D.; Burgess, J.; Gardner, M.; Hines, J.; Scott, B.; Kroenke, M.; Larson, J.; Lightner, M.; Turner, G.; et al. Characterization of the Isomericconfiguration and Impurities of (Z)-Endoxifen by 2D NMR, High Resolution LC-MS, and Quantitative HPLC Analysis. J. Pharm. Biomed. Anal. 2014, 88, 174–179. DOI: 10.1016/j.jpba.2013.07.010.
  • Saini, B.; Bansal, G. Characterization of Four New Photodegradation Products of Hydroxychloroquine through LC-PDA, ESI-MSn and LC-MS-TOF Studies. J. Pharm. Biomed. Anal. 2013, 84, 224–231. DOI: 10.1016/j.jpba.2013.06.014.
  • Dall’Acqua, S.; Vedaldi, D.; Salvador, A. Isolation and Structure Elucidation of the Main UV-a Photoproducts of Vandetanib. J. Pharm. Biomed. Anal. 2013, 84, 196–200. DOI: 10.1016/j.jpba.2013.05.049.
  • Namdev, D.; Borkar, R.-M.; Raju, B.; Kalariya, P.-D.; Rahangdale, V.-T.; Gananadhamu, S.; Srinivas, R. Identification of Forced Degradation Products of Tamsulosin Using Liquid Chromatography/Electrospray Ionization Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2014, 88, 245–255. DOI: 10.1016/j.jpba.2013.08.052.
  • Jingyan, S.; Yuwen, L.; Zhiyong, W.; Cunxin, W. Investigation of Thermal Decomposition of Ascorbic Acid by TG-FTIR and Thermal Kinetics Analysis. J. Pharm. Biomed. Anal. 2013, 77, 116–119. DOI: 10.1016/j.jpba.2013.01.018.
  • Bansal, G.; Singh, R.; Saini, B.; Bansal, Y. ESI-MSn and LC-ESI-MS Studies to Characterize Forced Degradation Products of Bosentan and a Validated Stability-Indicating LC-UV Method. J. Pharm. Biomed. Anal. 2013, 72, 186–197. DOI: 10.1016/j.jpba.2012.08.014.
  • Kaushik, D.; Bansal, G. Characterization of Degradation Products of Idarubicin through LC-UV, MSn and LC-MS-TOF Studies. J. Pharm. Biomed. Anal. 2013, 85, 123–131. DOI: 10.1016/j.jpba.2013.07.002.
  • Rao, R.-N.; Vali, R.-M.; Raju, S.-S. Liquid Chromatography Tandem Mass Spectrometric Studies of Indinavir Sulphate and Its Forced Degradation Products. J. Pharm. Biomed. Anal. 2013, 74, 101–110. DOI: 10.1016/j.jpba.2012.10.025.
  • Yuan, Y.-Z.; Zhang, M.; Fan, X.-L.; Hu, C.-Q.; Jin, S.-H.; Van Schepdael, A.; Hoogmartens, J.; Adams, E. Analysis of Impurities in Vertilmicin Sulfate by Liquid Chromatography Ion-Trap Mass Spectrometry. J. Pharm. Biomed. Anal. 2013, 80, 1–8. DOI: 10.1016/j.jpba.2013.02.026.
  • Kahsay, G.; Adegoke, A.-O.; Van Schepdael, A.; Adams, E. Development and Validation of a Reversed Phase Liquid Chromatographic Method for Analysis of Griseofulvin and Impurities. J. Pharm. Biomed. Anal. 2013, 80, 9–17. DOI: 10.1016/j.jpba.2013.02.035.
  • Mabrouk, M.; El-Fatatry, H.; Hewala, I.; Emam, E. Development and Application of a Novel, Dual-Mode Gradient, Stability-Indicating HPLC-DAD Method for the Simultaneous Determination and Purity Assessment of Mebeverine Hydrochloride, Diloxanide Furoate and Their Corresponding Major Degradation Products in Combination with Some Gastrointestinal Drugs in the Form of Oral Doses. J. Pharm. Biomed. Anal. 2013, 83, 249–259. DOI: 10.1016/j.jpba.2013.04.013.
  • Schmidt, A.-H.; Molnár, I. Using an Innovative Quality-by-Design Approach for Development of a Stability Indicating UHPLC Method for Ebastine in the API and Pharmaceutical Formulations. J. Pharm. Biomed. Anal. 2013, 78–79, 65–74. DOI: 10.1016/j.jpba.2013.01.032.
  • Murthy, M.-V.; Krishnaiah, C.; Srinivas, K.; Rao, K.-S.; Kumar, N.-R.; Mukkanti, K. Development and Validation of RP-UPLC Method for the Determination of Darifenacin Hydrobromide, Its Related Compounds and Its Degradation Products Using Design of Experiments. J. Pharm. Biomed. Anal. 2013, 72, 40–50. DOI: 10.1016/j.jpba.2012.09.013.
  • Vemić, A.; Jančić Stojanović, B.; Stamenković, I.; Malenović, A. Chaotropic Agents in Liquid Chromatographic Method Development for the Simultaneous Analysis of Levodopa, Carbidopa, Entacapone and Their Impurities. J. Pharm. Biomed. Anal. 2013, 77, 9–15. DOI: 10.1016/j.jpba.2013.01.007.
  • van Wijk, A.-M.; Niederländer, H.-A.; Siebum, A.-H.; Vervaart, M.-A.; de Jong, G.-J. A New Derivatization Reagent for LC-MS/MS Screening of Potential Genotoxic Alkylation Compounds. J. Pharm. Biomed. Anal. 2013, 74, 133–140. DOI: 10.1016/j.jpba.2012.10.004.
  • Vijaya Bhaskar Reddy, A.; Venugopal, N.; Madhavi, G.; Gangadhara Reddy, K.; Madhavi, V. A Selective and Sensitive UPLC-MS/MS Approach for Trace Level Quantification of Four Potential Genotoxic Impurities in Zolmitriptan Drug Substance. J. Pharm. Biomed. Anal. 2013, 84, 84–89. DOI: 10.1016/j.jpba.2013.05.047.
  • Locatelli, M.; De Lutiis, F.; Carlucci, G. High Performance Liquid Chromatography Determination of Prulifloxacin and Five Related Impurities in Pharmaceutical Formulations. J. Pharm. Biomed. Anal. 2013, 78–79, 27–33. DOI: 10.1016/j.jpba.2013.01.036.
  • CHROMacademy, Chapter 2, 3, 4 and 6, Reversed Phase Chromatogr. 1999, 3–18. http://www.chromacademy.com/lms/sco5/Theory-Of-HPLC-Reverse-Phase-Chromatography.pdf (accessed on 7 July, 2018)
  • Dong, M.-W. Modern HPLC for Practicing Scientists; Wiley: Hoboken, 2006.
  • Swartz, M. HPLC Detectors: A Brief Review. J. Liq. Chromatogr. Relat. Technol. 2010, 33, 1130–1150. DOI: 10.1080/10826076.2010.484356.
  • International Conference on Harmonisation, Q8 (R2): Pharmaceutical Development. ICH Harmonised Tripartite Guideline. 2009, 4, 1–24.
  • Peraman, R.; Bhadraya, K.; Padmanabha Reddy, Y. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytic. Int. J. Anal. Chem. 2015, 2015, 1–9. DOI: 10.1155/2015/868727.
  • Ramachandra, B. Development of Impurity Profiling Methods Using Modern Analytical Techniques. Crit. Rev. Anal. Chem. 2017, 47, 24–36. DOI: 10.1080/10408347.2016.1169913.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.