905
Views
11
CrossRef citations to date
0
Altmetric
Review Article

Impurities in Drug Products and Active Pharmaceutical Ingredients

&
Pages 187-193 | Published online: 01 Nov 2016

References

  • Bauer, M.; Möller, H. J.; Schneider, E. Duloxetine: A New Selective and Dual-acting Antidepressant. Expert Opin. Pharmacother. 2006, 7, 421–427.
  • Bundgaard, H.; De Weck, A. L. The Role of Amino-Reactive Impurities in Acetylsalicylic Acid Allergy. Int. Arch. Allergy Immunol. 1975, 49, 119–124.
  • Chhalotiya, U. K.; Bhatt, K. K.; Shah, D. A.; Baldania, S. L. Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage form. Scientia Pharmaceutica 2010, 78, 857–868.
  • Clegg, S.; Safe, S.; Crocker, J. F. S. Identification of a Toxic Impurity in Commercial Diphenylamine. J. Environ. Sci. Health, Part B. 1981, 16, 125–130.
  • Drug definition US FDA Drug Approval Process. Pharmacist Pharma J. 2010 http://www.pharmacistspharmajournal.org/2010/2011/definitions-of-drug-radioactive-drug_2011.html#.V2011SecNmLTIV.
  • Elshanawane, A. A.; Abdelaziz, L. M.; Kamal, M. M.; Hafez, H. M. Quantitative Determination of Telmisartan, Ramipril, Amlodipine Besylate, and Atorvastatin Calcium by HPLC. J. Liquid Chromatogr. Related Technol. 2013, 37, 195–206.
  • Ertürk, S.; Aktaş, E. S.; Ersoy, L.; Fiçicioǧlu, S. An HPLC Method for the Determination of Atorvastatin and its Impurities in Bulk Drug and Tablets. J. Pharmaceutical Biomed. Anal. 2003, 33, 1017–1023.
  • Gupta, L. K. Spectroscopic Characterization and Quantitative Determination of Atorvastatin Calcium Impurities by Novel HPLC Method. Spectrochim. Acta - Part A: Molecular Biomolecular Spectrosc. 2012, 97, 495–501.
  • Husain, S.; Nageswara Rao, R. Monitoring of Process Impurities in Drugs, Advanced Chromatographic and Electromigration Methods in Biosciences; Elsevier Science: Amsterdam, 1998, 834–888.
  • ICH. Impurities in new drug substances Q3A (R2), International Conference on Harmonization, Geneva, Switzerland, IFPMA, 2006.
  • IMS Top 20 Global Products, IMS Health MIDAS, DOI (2011) http://www.imshealth.com/files/web/Corporate/News/TopLine%20Market%20Data/Top_20_Global_Products.pdf.
  • IMS Top 20 Global Products, IMS Health MIDAS, DOI (2012) http://www.imshealth.com/files/web/Corporate/News/TopLine%20Market%20Data/2012/Top_2020_Global_Products_2012_2012.pdf.
  • IMS Top 20 Global Products, IMS Health MIDAS, DOI (2013) http://www.imshealth.com/files/web/Corporate/News/TopLine%20Market%20Data/Global%20Prescription%20Sales%20Information21Top_20_Global_Products_2013.pdf.
  • Jain, D.; Basniwal, P. K. Forced Degradation and Impurity Profiling: Recent Trends in Analytical Perspectives. J. Pharmaceutical Biomed. Anal. 2013, 86, 11–35.
  • Karagiannidou, E. G.; Bekiari, E. T.; Vastardi, E. I. A Validated RP-HPLC Method for the Analysis of 1-fluoronaphthalene and its Process-Related Impurities. J. Chromatogr. Sci. 2015, 53, 1296–1302.
  • Kowalski, A.; Frankowski, M. Levels and Potential Health Risks of Mercury in Prescription, Non-Prescription Medicines and Dietary Supplements in Poland. Regulatory Toxicol. Pharmacol. 2015, 73, 396–400.
  • Kumar, N.; Sangeetha, D.; Vaghela, B.; Reddy, P. S.; Raghav, A. Development and Validation of a Stability Indicating RP-LC Method for the Estimation of Process Related Impurities and Degradation Products of Duloxetine Hydrochloride and Phthalic Acid in Duloxetine Hydrochloride Delayed Release Capsules. J. Liquid Chromatogr. Related Technol. 2012, 35, 867–881.
  • Londhe, S. V.; Deshmukh, R. S.; Mulgund, S. V.; Jain, K. S. Development and Validation of a Reversed-phase HPLC Method for Simultaneous Determination of Aspirin, Atorvastatin Calcium and Clopidogrel Bisulphate in Capsules. Indian J. Pharmaceutical Sci. 2011, 73, 23–29.
  • Maggio, R. M.; Calvo, N. L.; Vignaduzzo, S. E.; Kaufman, T. S. Pharmaceutical Impurities and Degradation Products: Uses and Applications of NMR techniques. J. Pharmaceutical Biomed. Anal. 2014, 101, 102–122.
  • Matveeva, O. A.; Kovaleva, E. L. Modern Approaches to Estimating the Content of Genotoxic Impurities in Drugs (a Review). Pharmaceutical Chem. J. 2016, 49, 765–770.
  • Mercolini, L.; Mandrioli, R.; Cazzolla, R.; Amore, M.; Raggi, M. A. HPLC Analysis of the Novel Antidepressant Duloxetine in Human Plasma After an Original Solid-phase Extraction Procedure. J. Chromatogr. B: Analytical Technol. Biomed. Life Sci. 2007, 856, 81–87.
  • Mohammadi, A.; Rezanour, N.; Ansari Dogaheh, M.; Ghorbani Bidkorbeh, F.; Hashem, M.; Walker, R. B. A Stability-Indicating High Performance Liquid Chromatographic (HPLC) Assay for the Simultaneous Determination of Atorvastatin and Amlodipine in Commercial Tablets. J. Chromatogr. B: Analytical Technol. Biomed. Life Sci. 2007, 846, 215–221.
  • Nageswara Rao, R.; Nagaraju, V. An Overview of the Recent Trends in Development of HPLC Methods for Determination of Impurities in Drugs. J. Pharmaceutical Biomed. Anal. 2003, 33, 335–377.
  • Nováková, L.; Šatínský, D.; Solich, P. HPLC Methods for the Determination of Simvastatin and Atorvastatin. TrAC - Trends in Analytical Chem. 2008, 27, 352–367.
  • Patil, P. P.; Kasture, V.S.; Prakash, K. V. Impurity Profiling Emerging Trends in Quality Control of Pharmaceuticals. Int. J. Pharmaceutical Chem. 2015, 5, 1–10.
  • Puranik, M.; Wadher, S.; Sharma, K. A Simple, Novel Validated Stability Indicating RP-HPLC Method for Estimation of Duloxetine HCL in Capsule Pharmaceutical Formulation. Indian J. Pharmaceutical Education Res. 2014, 48, 91–98.
  • Qiu, F.; Norwood, D. L. Identification of Pharmaceutical Impurities. J. Liquid Chromatogr. Related Technol. 2007, 30, 877–935.
  • Raman, N. V.; Harikrishna, K. A.; Prasad, A. V.; Reddy, K. R.; Ramakrishna, K. Determination of Duloxetine Hydrochloride in the Presence of Process and Degradation Impurities by a Validated Stability-Indicating RP-LC Method. J. Pharmaceutical Biomed. Anal. 2010, 51, 994–997.
  • Ramesha, B.; Reddy, K. R. V.; Kishore, B. V.; Kumar Amith, M. K.; Raju, L. P.; Thara, B. N. Development and Validation of a Stability-Indicating Gradient RP-UHPLC Method for the Determination of Impurities in Atorvastatin Drug Substance. J. Liquid Chromatogr. Related Technol. 2014, 37, 275–297.
  • Rao, D. D.; Sait, S. S.; Reddy, A. M.; Chakole, D.; Reddy, Y. R.; Mukkanti, K. Analysis of Duloxetine Hydrochloride and its Related Compounds in Pharmaceutical Dosage forms and in Vitro Dissolution Studies by Stability Indicating UPLC. J. Chromatogr. Sci. 2010, 48, 819–824.
  • Reddy, P. R. M.; Sreeramulu, J.; Naidu, P. Y.; Reddy, A. R. Stability Indicating fast LC for the Simultaneous Estimation of Intermediates and Degradants of Duloxetine Hydrochloride. Chromatographia. 2010, 71, 95–100.
  • Reddy, A. V.; Sreenivas Ulareddy, B. M.; Kameshwar Rao, K. R.; Madhusudhanreddy, B. Stability Indicating Nature of RP-HPLC Method for Determination of Impurity Profile and Degradation Impurities in Duloxetine Hydrochloride. Der. Pharma Chemica. 2012, 4, 1735–1741.
  • Sangshetti, J. N.; Aqeel, M.; Zaheer, Z.; Ahmed, R. Z.; Dehghan, M. H. G.; Gonjari, I. Development and Validation of RP-HPLC Method for Determination of Atorvastatin Calcium and Nicotinic Acid in Combined Tablet Dosage form. J. Saudi Chem. Soc. 2012.
  • Shah, D. A.; Bhatt, K. K.; Mehta, R. S.; Baldania, S. L.; Gandhi, T. R. Stability Indicating RP-HPLC Estimation of Atorvastatin Calcium and Amlodipine Besylate in Pharmaceutical Formulations. Indian J. Pharmaceutical Sci. 2008, 70, 754–760.
  • Soni, P.; Mariappan, T. T.; Banerjee, U. C. High-Performance Liquid Chromatographic Method for the Simultaneous Estimation of the key Intermediates of Duloxetine. Talanta. 2005, 67, 975–978.
  • Srinivasulu, P.; Srinivas, K. S.; Reddy, R. S.; Mukkanti, K.; Buchireddy, R. A Validated Stability Indicating Rapid LC Method for Duloxetine HCl. Pharmazie. 2009, 64, 10–13.
  • Stach, J.; Havlíček, J.; Plaček, L.; Rádl, S. Synthesis of Some Impurities and/or Degradation Products of Atorvastatin. Collection of Czechoslovak Chem. Commun. 2008, 73, 229–246.
  • Vadlamudi, M. K.; Dhanaraj, S.; Yarkala, S.; Jayapal, J. J.; Kommavarapu, P. K. Development of Stability Indicating RP-HPLC Method for the Determination of Related Substances in Atorvastatin Solid Dosage form and Bulk Drugs. Int. J. Pharmacy Pharmaceutical Sci. 2015, 7, 184–194.
  • Vora, D. N.; Kadav, A. A. Validated Ultra HPLC Method for the Simultaneous Determination of Atorvastatin, Aspirin, and Their Degradation Products in Capsules. J. Liquid Chromatogr. Related Technol. 2008, 31, 2821–2837.
  • Vukkum, P.; Moses Babu, J.; Muralikrishna, R. Stress Degradation Behavior of Atorvastatin Calcium and Development of a Suitable Stability-Indicating LC Method for the Determination of Atorvastatin, its Related Impurities, and its Degradation Products. Scientia Pharmaceutica. 2013, 81, 93–114.

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.