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Review Articles

Stability Indicating Methods for Determination of Third Generation Antiepileptic Drugs and Their Related Substances

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Pages 1524-1536 | Published online: 06 Mar 2021

References

  • World Health Organization. Epilepsy. https://www.who.int/news-room/fact-sheets/detail/epilepsy. (accessed Sept 13, 2020).
  • Moshé, S. L.; Perucca, E.; Ryvlin, P.; Tomson, T. Epilepsy: New Advances. Lancet 2015, 385, 884–898. DOI: 10.1016/S0140-6736(14)60456-6.
  • Sills, G. J.; Rogawski, M. A. Mechanisms of Action of Currently Used Antiseizure Drugs. Neuropharmacology 2020, 168, 107913–107966. DOI: 10.1016/j.neuropharm.2020.107966.
  • Landmark, C. J.; Johannessen, S. I.; Patsalos, P. N. Therapeutic Drug Monitoring of Antiepileptic Drugs: Current Status and Future Prospects. Expert Opin. Drug Metab. Toxicol. 2020, 16, 227–238. DOI: 10.1080/17425255.2020.1724956.
  • Singh, K. P.; Verma, N. Teratogenic Potential of Third-Generation Antiepileptic Drugs: Current Status and Research Needs. Pharmacol. Rep. 2019, 71, 491–502. DOI: 10.1016/j.pharep.2019.01.011.
  • Patsalos, P.; Spencer, E.; Berry, D. Therapeutic Drug Monitoring of Antiepileptic Drugs in Epilepsy: A 2018 Update. Ther. Drug Monit. 2018, 40, 526–548. DOI: 10.1097/FTD.0000000000000546.
  • Maggio, R. M.; Vignaduzzo, S. E.; Kaufman, T. S. Practical and Regulatory Considerations for Stability-Indicating Methods for the Assay of Bulk Drugs and Drug Formulations. TrAC - Trends Anal. Chem. 2013, 49, 57–70. DOI: 10.1016/j.trac.2013.05.008.
  • Santulli, L.; Coppola, A.; Balestrini, S.; Striano, S. The Challenges of Treating Epilepsy with 25 Antiepileptic Drugs. Pharmacol. Res. 2016, 107, 211–219. DOI: 10.1016/j.phrs.2016.03.016.
  • de Biase, S.; Nilo, A.; Bernardini, A.; Gigli, G. L.; Valente, M.; Merlino, G. Timing Use of Novel anti-Epileptic Drugs: Is Earlier Better? Expert Rev. Neurother. 2019, 19, 945–954. DOI: 10.1080/14737175.2019.1636649.
  • Perucca, E.; Brodie, M. J.; Kwan, P. Tomson, T. 30 Years of Second-Generation Antiseizure Medications: Impact and Future Perspectives. Lancet Neurol. 2020, 4422, 1–12. DOI: 10.1016/s1474-4422(20)30035-1.
  • Liu, D. Q.; Sun, M.; Kord, A. S. Recent Advances in Trace Analysis of Pharmaceutical Genotoxic Impurities. J. Pharm. Biomed. Anal. 2010, 51, 999–1014. DOI: 10.1016/j.jpba.2009.11.009.
  • International Conference Harmonisation Q3A (R2): Impurities in New Drug Substances, ICH Harmon. Tripart. Guidel, 2006.
  • International Conference on Harmonisation. Q3B (R2): Impurities in New Drug Products. ICH Harmon. Tripart. Guidel, 2006.
  • 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.
  • EMA. Inovelon, Rufinamide. https://www.ema.europa.eu/en/medicines/human/EPAR/inovelon. (accessed Aug 17, 2020).
  • FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 021911. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=021911. (accessed Aug 17, 2020).
  • EMA. Diacomit, Stiripentol. https://www.ema.europa.eu/en/medicines/human/EPAR/diacomit. (accessed Aug 17, 2020).
  • FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 206709. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206709. (accessed Aug 17, 2020).
  • EMA. Vimpat, Lacosamide. https://www.ema.europa.eu/en/medicines/human/EPAR/vimpat. (accessed Aug 15, 2020).
  • FDA. FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 022253. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022253. (accessed Aug 15, 2020).
  • EMA. Zebinix, Esliscarbazepine Acetate. https://www.ema.europa.eu/en/medicines/human/EPAR/zebinix. (accessed Aug 15, 2020).
  • FDA. FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 211199. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211199. (accessed Aug 15, 2020).
  • EMA. Fycompa, Perampanel. https://www.ema.europa.eu/en/medicines/human/EPAR/fycompa. (accessed Aug 15, 2020).
  • FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 208277. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=208277. (accessed Aug 15, 2020).
  • EMA. Briviact, Brivaracetam. https://www.ema.europa.eu/en/medicines/human/EPAR/briviact-italy-nubriveo#authorisation-details-section. (accessed Aug 15, 2020).
  • FDA. FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 205836. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205836. (accessed Aug 15, 2020).
  • EMA. Votubia, Everolimus. https://www.ema.europa.eu/en/medicines/human/EPAR/votubia. (accessed Aug 15, 2020).
  • FDA. Drugs@FDA: FDA-Approved Drugs. New Drug Application (NDA): 022334. H https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022334. (accessed Aug 17, 2020).
  • Rogawski, M. A.; Löscher, W.; Rho, J. M. Mechanisms of Action of Antiseizure Drugs and the Ketogenic Diet. Cold Spring Harb. Perspect. Med. 2016, 6, a022780–28. DOI: 10.1101/cshperspect.a022780.
  • Scifinder. https://scifinder.cas.org (acessed May, 2020).
  • Pubchem. hppts://pubchem.ncbi.nlm.nih.gov/ (acessed May, 2020).
  • Almeida, L.; Soares-da-Silva, P. Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics 2007, 4, 88–96. DOI: 10.1016/j.nurt.2006.10.005.
  • Hibi, S.; Ueno, K.; Nagato, S.; Kawano, K.; Ito, K.; Norimine, Y.; Takenaka, O.; Hanada, T.; Yonaga, M. Discovery of 2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl)benzonitrile (perampanel): A Novel, Noncompetitive α-Amino-3-hydroxy-5-methyl-4-isoxazolepropanoic acid (AMPA) Receptor Antagonist. J. Med. Chem. 2012, 55, 10584–10600. DOI: 10.1021/jm301268u.
  • Perucca, E.; Cloyd, J.; Critchley, D.; Fuseau, E. Rufinamide: Clinical Pharmacokinetics and Concentration-Response Relationships in Patients with Epilepsy. Epilepsia 2008, 49, 1123–1141. DOI: 10.1111/j.1528-1167.2008.01665.x.
  • Trojnar, M. K.; Wojtal, K.; Trojnar, M. P.; Czuczwar, S. J. Stiripentol. A Novel Antiepileptic Drug. Pharmacol. Rep. 2005, 57, 154–160.
  • Czuczwar, S. J.; Trojnar, M. K.; Gergont, A.; Kroczka, S.; Kacinski, M. Stiripentol - Characteristic of a New Antiepileptic Drug. Expert Opin. Drug Discov. 2008, 3, 453–460. DOI: 10.1517/17460441.3.4.453.
  • Beyreuther, B. K.; Freitag, J.; Heers, C.; Krebsfänger, N.; Scharfenecker, U.; Stöhr, T. Lacosamide: A Review of Preclinical Properties. CNS Drug Rev. 2007, 13, 21–42. DOI: 10.1111/j.1527-3458.2007.00001.x.
  • Rogawski, M. A.; Tofighy, A.; White, H. S.; Matagne, A.; Wolff, C. Current Understanding of the Mechanism of Action of the Antiepileptic Drug Lacosamide. Epilepsy Res. 2015, 110, 189–205. DOI: 10.1016/j.eplepsyres.2014.11.021.
  • Rocamora, R. A Review of the Efficacy and Safety of Eslicarbazepine Acetate in the Management of Partial-Onset Seizures. Ther. Adv. Neurol. Disord. 2015, 8, 178–186. DOI: 10.1177/1756285615589711.
  • Malawska, B.; Kulig, K. Brivaracetam: A New Drug in Development for Epilepsy and Neuropathic Pain. Expert Opin. Investig. Drugs 2008, 17, 361–369. DOI: 10.1517/13543784.17.3.361.
  • Qiu, S.; Tehrani, K. A.; Sergeyev, S.; Bultinck, P.; Herrebout, W.; Mathieu, B. Stereochemistry of the Brivaracetam Diastereoisomers. Chirality 2016, 28, 215–225. DOI: 10.1002/chir.22558.
  • European Medicines Agency, E. Votubia, Everolimus. Comm. Med. Prod. Hum. Use. 2011, 44, 0–88.
  • Jang, S. W.; Kang, M. J. Improved Oral Absorption and Chemical Stability of Everolimus via Preparation of Solid Dispersion Using Solvent Wetting Technique. Int. J. Pharm. 2014, 473, 187–193. DOI: 10.1016/j.ijpharm.2014.06.006.
  • Moraes do Carmo, A. C.; Pereira, R. S.; Gratieri, T. Brazilian Requirements for Stability Indicating Methods. TrAC - Trends Anal. Chem. 2018, 98, 58–63. DOI: 10.1016/j.trac.2017.10.017.
  • Sengupta, P.; Chatterjee, B.; Tekade, R. K. Current Regulatory Requirements and Practical Approaches for Stability Analysis of Pharmaceutical Products: A Comprehensive Review. Int. J. Pharm. 2018, 543, 328–344. DOI: 10.1016/j.ijpharm.2018.04.007.
  • Ramachandra, B. Critical Reviews in Analytical Chemistry Development of Impurity Profiling Methods Using Modern Analytical Techniques. Crit. Rev. Anal. Chem. 2017, 47, 24–36. DOI: 10.1080/10408347.2016.1169913.
  • Zhang, K.; Kurita, K. L.; Venkatramani, C.; Russell, D. Seeking Universal Detectors for Analytical Characterizations. J. Pharm. Biomed. Anal. 2019, 162, 192–204. DOI: 10.1016/j.jpba.2018.09.029.
  • USP. United States Pharmacopeia, 43th ed.; United States Convention: Rockville, 2020.
  • Eur. Ph. European Pharmacopoeia, 10th Ed.; Council of Europe: Strasbourg, 2019.
  • Annapurna, M. M.; Goutam, S.; Pavani, S. New Stability Indicating Liquid Chromatographic Method for the Determination of Rufinamide in Presence of Degradant Products. Drug Invent. Today 2012, 4, 501–506. DOI: 10.5958/0974-360X.2018.00705.9.
  • Mahamuni, B. S.; Srinivas, R.; Talluri, M. V K. Characterization of Forced Degradation Products of Rufinamide by LC/QTOF/MS/MS, NMR and IR Studies. Anal. Chem. Lett. 2018, 8, 405–415. DOI: 10.1080/22297928.2018.1438315.
  • Kumar, B. S. P.; Annapurna, M. M.; Pavani, S. Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Rufinamide. J. Pharm. Anal. 2013, 3, 66–70. DOI: 10.1016/j.jpha.2012.08.003.
  • Patel, A.; Suhagia, B. N.; Patwari, A. Development and Validation of Stability Indicating HPLC Method for Estimation of Rufinamide in Bulk and Its Pharmaceutical Dosage Form. World J. Pharm. Res. 2014, 3, 1798–1810.
  • Hassib, S. T.; Hashem, H. M. A.; Mahrouse, M. A.; Mostafa, E. A. Determination of Rufinamide in the Presence of 1-[(2,6-Difluorophenyl)Methyl]-1H-1,2,3-Triazole-4 Carboxylic Acid Using RP-HPLC and Derivative Ratio Methods as Stability Indicating Assays to Be Applied on Dosage Form. J. AOAC Int. 2020, 103, 1–8. DOI: 10.1093/jaoacint/qsaa020.
  • Annapurna, M. M.; Kumar, B. S. P.; Goutam, S.; Srinivas, L. Stability Indicating Liquid Chromatographic Method for the Quantitative Determination of Rufinamide in Pharmaceutical Dosage Forms. J. Drug Deliv. Ther. 2012, 2, 167–174. DOI: 10.22270/jddt.v3i3.498.
  • Ngumo, P.; Abuga, K. O.; Njogu, P. M.; Ongarora, D. S. B. A Stability Indicating Liquid Chromatography Method for the Assay of Rufinamide Bulk Material and Tablets. East Cent. African J. Pharm. Sci. 2016, 19, 16–21. DOI: 10.1017/CBO9781107415324.004.
  • Snyder, J. K. Introduction to Modern Liquid Chromatography, John Wiley and Sons, New York, 2011.
  • Ranjith, K.; Rao, M.; Murthy, T. Development and Validation of Related Substances Method for Rufinamide Tablets by RP-HPLC. J. Chem. Pharm. Res. 2017, 4, 306–314. DOI: 10.26420/austinjanalpharmchemg.2017.1087.
  • Geetha, M.; Sait, S.; Sripal Reddy, P. A Stability Indicating UPLC Method for the Estimation of Related Substances, Assay and Dissolution of Rufinamide. Asian J. Chem. 2013, 25, 9775–9778. DOI: 10.14233/ajchem.2013.15314.
  • Patel, A.; Patwari, A.; Suhagia, B. Development of a Validated Stability-Indicating HPTLC Method for Rufinamide in Bulk and Its Pharmaceutical Dosage Form. J. Chromatogr. Sci. 2014, 52, 1294–1301. DOI: 10.1093/chromsci/bmt171.
  • Darwish, H. W.; Abdelhameed, A. S.; Attia, M. I.; Bakheit, A. H.; Khalil, N. Y.; Al-Majed, A. A. A. A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form. J Anal Methods Chem. 2014, 2014, 638910–638951. DOI: 10.1155/2014/638951.
  • Shah, S.; Vasantharaju, S. G.; Karthik, A.; Muddukrishna, B. S. Development and Validation of Stability-Indicating Assay Method for Lacosamide by RP- HPLC. Elixir Int. J. 2011, 38, 4174–4177.
  • Sreenivasulu, V.; Rao, D. R.; Maheswari, B. N. U.; Das, S. K.; Krishnaiah, A. Development and Validation of a Stabiliting-Indicating RP-HPLC Method for Determination of Lacosamide. Res. J. Pharm. Biol. Chem. Sci. 2011, 2, 1–11.
  • Chhalotiya, U. K.; Bhatt, K. K.; Shah, D. A.; Baldania, S. L.; Patel, J. R. Stability-Indicating Liquid Chromatographic Method for Quantification of New anti-Epileptic Drug Lacosamide in Bulk and Pharmaceutical Formulation. CI&CEQ. 2012, 18, 35–42. DOI: 10.2298/CICEQ110821044C.
  • Chakravarthy, V. K.; Sankar, D. G. Stability Indicating Hplc Method for Determination of Lacosamide and Its Degradants/Impurities in Bulk and Pharmaceutical Formulation. Rasayan J. Chem. 2012, 5, 293–310.
  • Patil, S. N.; Agrawal, P. N.; Kadam, A.; Manish, M.; Askshay, S. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Formulations. Int. J. Pharm. Sci. Rev. Res. 2014, 28, 164–168.
  • Tiwari, R. N.; Bonde, C. G. Identification and Characterization of Degradation Products of Lacosamide by Liquid-Chromatography/Time-of-Flight Mass Spectrometric and Multi-Stage Mass Spectrometric Analysis. J. Liq. Chromatogr. Relat. Technol. 2014, 37, 2046–2061. DOI: 10.1080/10826076.2013.825860.
  • 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.
  • Mahesh, H. R. K.; Babu, S. K. Quantitative Estimation of Related Compounds of Lacosamide in Oral Solution by Using Reverse Phase HPLC. Der Pharm. Lett. 2015, 7, 285–291.
  • Kalyan Chakravarthy, V.; Gowri Shankar, D. HPLC Method for Determination of Lacosamide S(-)Enantiomer in Bulk and Pharmaceutical Formulation. Rasayan J. Chem. 2011, 4, 744–752.
  • Parmar, M.; Nimavat, K.; Vyas, K.; Rao, D.; Pande, R. A Stability-Indicating Liquid Chromatographic Method for the Quantification of New anti-Epileptic Drug Lacosamide and Its Intermediates. Int. J. Pharm. Res. Sch. 2012, 1, 40–47.
  • Charagondla, K. A Validated Chiral Liquid Chromatographic Method for the Enantiomeric Separation of Lacosamide Drug Product and Its Dosage Forms. J. Chromatogr. Sep. Tech 2015, 06, 1–9. DOI: 10.4172/2157-7064.1000280.
  • Zhou, N.; Li, T.; Ai, L.; Guo, C.; Zhang, J.; Fu, S.; Wang, Q. Identification of Forced Degradation Products of Lacosamide by LC-QQLIT-MS and LC-IT/TOF-MS. Acta Chromatogr. 2019, 31, 12–18. DOI: 10.1556/1326.2018.00279.
  • Molleti, S.; Rao, V.; Jayaveera, K. N. Stability Indicating RP-UPLC Method for the Determination of Lacosamide and Its Impurities in Bulk Drugs and Its Pharmaceutical Dosage Forms. Der. Pharma. Chem. 2013, 5, 81–89.
  • Patel, A.; Suhagia, B. N.; Patwari, A. Stability Indicating Assay Method for Quantification of Lacosamide in Bulk and Its Pharmaceutical Dosage Form and Characterization of Major Degradation Products. Int. J. Pharm. Pharm. Sci. 2013, 6, 593–599.
  • Korany, M. A.; Mahgoub, H.; Haggag, R. S.; Ragab, M. A. A.; Elmallah, O. A. Green Gas Chromatographic Stability-Indicating Method for the Determination of Lacosamide in Tablets. Application to in-Vivo Human Urine Profiling. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2018, 1083, 75–85. DOI: 10.1016/j.jchromb.2018.02.033.
  • Mone, M. K.; Chandrasekhar, K. B. Development of Liquid Chromatographic Enantiomer Separation Methods and Validation for the Estimation of (R)-Enantiomer in Eslicarbazepine Acetate. J. Pharm. Biomed. Anal. 2011, 54, 248–251. DOI: 10.1016/j.jpba.2010.08.015.
  • Thomas, S.; Bharti, A.; Maddhesia, P. K.; Shandilya, S.; Agarwal, A.; Dharamvir; Biswas, S.; Bhansal, V.; Gupta, A. K.; Tewari, P. K.; Mathela, C. S. Highly Efficient, Selective, Sensitive and Stability Indicating RP-HPLC-UV Method for the Quantitative Determination of Potential Impurities and Characterization of Four Novel Impurities in Eslicarbazepine Acetate Active Pharmaceutical Ingredient by LC/ES. J. Pharm. Biomed. Anal. 2012, 61, 165–175. DOI: 10.1016/j.jpba.2011.11.024.
  • Thomas, S.; Paul, S. K.; Joshi, S. C.; Kumar, V.; Agarwal, A.; Vir, D. Vir, D. Identification, Synthesis and Characterization of an Unknown Process Related Impurity in Eslicarbazepine Acetate Active Pharmaceutical Ingredient by LC/ESI-IT/MS, 1H, 13C and 1H-1H COSY NMR. J. Pharm. Anal. 2014, 4, 339–344. DOI: 10.1016/j.jpha.2013.08.004.
  • Srinivas, M.; Avupati, N. R.; Sait, S.; Mukkanti, K. Stability Indicating HPLC Method for the Determination of Eslicarbazepine Acetate and Its Impurities in Bulk Drugs and Pharmaceutical Dosage Forms. J. Liq. Chromatogr. Relat. Technol. 2012, 35, 1550–1564. DOI: 10.1080/10826076.2011.619043.
  • Kallam, S. R.; Srikanth, J.; Prakash, K. V. Development and Validation of an RP-HPLC Method for Related Substance and Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Pharmaceutical Dosage Form. J. Pharm. Biol. Sci. 2015, 10, 155–162. DOI: 10.9790/3008-1062155162.
  • Iram, F.; Alam, P.; Siddiqui, N. A.; Alqasoumi, S. I.; Siddiqui, A. A.; Khan, S. A.; Husain, A. Development of a Stress Induced Validated UPLC-PDA Method for the Analysis of Eslicarbazepine Acetate. Saudi Pharm J 2018, 26, 286–291. DOI: 10.1016/j.jsps.2017.11.009.
  • Patel, C. J.; Patel, S. S.; Patel, M. M. Method Development and Stability Study by Chromatographic Method for Perampanel in API and Tablet Dosage Form. Int. J. Pharm. Drug Anal. 2017, 5, 229–240.
  • Xia, Y.-Y.; Zou, Q.-G.; Yang, Y.-F.; Sun, Q.; Han, C.-Q. Determination of Impurities in Perampanel Bulk Drugs by High-Performance Liquid Chromatography and Gas Chromatography. Curr. Pharm. Anal. 2020, 16, 1–12. DOI: 10.2174/1573412916999200513105657.
  • Annapurna, M. M.; Kaibada, R.; Srinivas, M. New Stability Indicating Rp-Ultra Fast Liquid Chromatographic Method for the Determination of Perampanel–an Antiepileptic Drug. Rese. J. Pharm. Technol. 2019, 12, 2657–2663. DOI: 10.5958/0974-360X.2019.00444.X.
  • Saida, S. J.; Muthuchamy, M.; Kaliyaperumal, M.; Rumalla, S.; Yanaka, R.; Rao, S. Isolation and Spectral Characterization of Degradation Impurity in Perampanel Drug Substance Using UPLC-MS and NMR Spectroscopy: Validation of Assay Method by UPLC. Asian J. Chem. 2018, 30, 2215–2219. DOI: 10.14233/ajchem.2018.21405.
  • Mali, N. V.; Mhaske, D. V. HPLC Studies on Degradation Behavior of Brivaracetam and Development of Validated Stability – Indicating HPLC Assay Method. IJSRM Human 2016, 4, 43–57.
  • Bhamare, P.; Umadoss, P.; Upmanyu, N.; Dubey, R. Identification, Isolation, Structural Characterisation, Synthesis and in-Silico Toxicity Prediction of Alkaline Hydrolytic Degradation Product of Brivaracetam by Using LC-PDA, Preparative HPLC, LC/HESI/LTQ, FTIR, 1H NMR. Anal. Methods 2020, 12, 1868–1881. DOI: 10.1039/C9AY02582K.
  • Vishweshwar, V.; Babu, J. M.; Muralikrishna, R.; Pharmaceutical, C.; Pradesh, A. Development and Validation of Stability-Indicating Uplc Method for the Determination of Brivaracetam, Its Related Impurities and Degradation Products. Int. J. Pharm. Sci. Res. 2018, 9, 2315–2327. DOI: 10.13040/IJPSR.0975-8232.9(6).2315-27.
  • Baksam, V.; Saritha, N.; Pocha, V. R.; Chakka, V. B.; Ummadi, R. R.; Kumar, P. Development of an Effective Novel Validated Stability-Indicating HPLC Method for the Resolution of Brivaracetam Stereoisomeric Impurities. Chirality 2020, 32, 1208–1212. DOI: 10.1002/chir.23269.
  • Sharmila, D.; Rao Lakshmana, A.; Kalyani, L. Development and Validation of Stability-Indicating High Performance Liquid Chromatographic Method for the Estimation of Everolimus in Tablets. Indian J. Pharm. Sci. 2015, 77, 599–604. DOI: 10.4103/0250-474x.169044.
  • Prasad, S. S.; Krishna Mohan, G. V.; Naga Babu, A. Development of Simple and Robust RP-HPLC Method for Determination of Everolimus and Its Impurities in Oral Solid Dosage Form. Asian J. Chem. 2019, 31, 1002–1008. DOI: 10.14233/ajchem.2019.21723.
  • Kumaraswamy, G.; Lalitha, R.; Vijaypraksh, K. Method Development and Validation for Estimation of Rufinamide in Tablet Dosage Forms by RP-HPLC. Int. J. Pharma. Chem. Anal. 2016, 3, 99. DOI: 10.5958/2394-2797.2016.00015.0.
  • Parashar, V.; Todkar, M.; Shaikh, F.; Reddy, S.; Mehra, V.; Sinha, S. Validated Liquid Chromatographic Method for Quantitative Determination of Rufinamide Active Pharmaceutical Ingredient Form and Its Impurities. Pharm. Methods 2013, 4, 6–10. DOI: 10.1016/j.phme.2013.08.001.
  • Mohamed, F. A.; Bakr, M. F.; Rageh, A. H.; Mostafa, A. M. The Use of Separation Techniques in the Analysis of Some Antiepileptic Drugs: A Critical Review. J. Liq. Chromatogr. Relat. Technol. 2016, 39, 783–798. DOI: 10.1080/10826076.2016.1266654.
  • Valarmathi, R.; Banu, S. F.; Akilandeswari, S.; Senthamarai, R.; Dhivya, C. S. A Review on New Antiepileptic Drug – Lacosamide and Its Analytical Methods. Int. J. Pharm. Chem. Sci. 2013, 2, 181–186.
  • Mali, N. V.; Bansode, D. A. Stability Indicating Thin-Layer Chromatographic Determination of Eslicarbazepine Acetate as Bulk Drug: Application to Forced Degradation Study. Der Pharm. Lett. 2016, 8, 38–47.
  • Narayanam, M.; Sahu, A.; Singh, S. Use of LC-MS/TOF, LC-MS(n), 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.

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