Development of a stability-indicating UPLC method for determination of olmesartan medoxomil and its degradation products in active pharmaceutical ingredient and dosage forms

Journal of Liquid Chromatography and Related Technologies

Volumn 35, Issue 8, 2012, Pages 1011-1026

  Raj, Shiva ^a   Siva Kumari, K ^b   Narasimha Rao, A ^b   Ugandhar Reddy, I ^b   Naga Raju, M ^b  

^a OSMANIA UNIVERSITY   (India)

^b DR REDDY'S LABORATORIES LTD   (India)

Author keywords

Angiotensin; Forced degradation; Olmesartan medoxomil; Stability indicating; UPLC; Validation

Indexed keywords

ANGIOTENSIN; FORCED DEGRADATION; OLMESARTAN MEDOXOMIL; STABILITY-INDICATING; UPLC; VALIDATION;

DEGRADATION; ISOMERS; LIQUID CHROMATOGRAPHY;

DRUG PRODUCTS;

OLMESARTAN; PHENYL GROUP;

ACCURACY; ARTICLE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG HYDROLYSIS; DRUG IMPURITY; DRUG OXIDATION; ELUTION; FLOW RATE; LABORATORY DEVICE; LIMIT OF DETECTION; LIMIT OF QUANTITATION; OXIDATIVE STRESS; PHOTOLYSIS; REACTION TIME; TEMPERATURE; TEMPERATURE STRESS; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

EID: 84859924384     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826076.2011.615091     Document Type: Article

References (23)

1. Caglar, S.; Onal, A. Two Simple and Rapid Spectrophotometric Methods for the Determination of a New Antihypertensive Drug Olmesartan in Tablets. J. Anal. Chem. 2010, 65, 239-243.
2. Trivedi, P.; Kartikeyan, C.; Kachave, R.; Bhadane, R. Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and Its Metabolite. J. Liq. Chrom. R. T. 2009, 32, 1516-1526.
3. Rane, V. P.; Patil, K. R.; Sangshetti, J. N.; Yeole, R. D.; Shinde, D. B. Stability-Indicating LC Method for the Determination of Olmesartan in Bulk Drug and in Pharmaceutical Dosage Form. Chromatographia 2009, 69, 169-173.
4. Bajerski, L.; Rossi, R. C.; Dias, C. L.; Bergold, A. M.; Froëhlich, P. E. Stability-Indicating LC Determination of a New Antihypertensive, Olmesartan Medoxomil in Tablets. Chromatographia 2008, 68, 991-996.
5. Vaidya, V. V.; Roy, S. M.N.; Yetal, S. M.; Joshi, S. S.; Parekh, S. A. LC-MS-MS Determination of Olmesartan in Human Plasma. Chromatographia 2007, 67, 147-150.
6. Çelebier, M.; Altinöz, S. Development of a CZE Method for the Determination of Olmesartan Medoxomil in Tablets. Chromatographia 2007, 66, 929-933. (Pubitemid 350211964)
7. Srihari Babu, K.; Tagore, A. R.; Reddy, G. S.; Venkateswarlu, G.; Reddy, P. P.; Anand, R. V. Synthesis of Related Substances of Olmesartan Medoxomil, Anti-Hypertensive Drug. Arkivoc 2010, ii, 92-302.
8. Liu, D.; Hu, P.; Matsushima, N.; Li, X.; Li, L.; Jiang, J. Quantitative Determination of Olmesartan in Human Plasma and Urine by Liquid Chromatography Coupled to Tandem Mass Spectrometry. J. Chromatogr. B. 2007, 56, 190-197. (Pubitemid 47302911)
9. Murakamia, T.; Konno, H.; Fukutsu, N.; Onodera, M.; Kawasaki, T.; Kusu, F. Identification of a Degradation Product in Stressed Tablets of Olmesartan Medoxomil by the Complementary Use of HPLC Hyphenated Techniques. J. Pharm. Biomed. Anal. 2008, 47, 553-559.
10. Moussa, B.; Mohamed, M.; Youssef, N. Acid- Alkali Degradation Study on Olmesartan Medoxomil and Development of Validated Stability-Indicating Chromatographic Methods. J. Chil. Chem. Soc.> [online]. 2010, 55 (2) [cited 2011-07-21], 199-202.
11. Sharma, R. N.; Pancholi, S. S. RP-HPLC-DAD Method for Determination of Olmesartan Medoxomil in Bulk and Tablets Exposed to Forced Conditions. Acta Pharm. 2010, 60, 13-24.
12. ICH Q1A (R2). Stability Testing of New Drug Substances and Products, IFPMA: Geneva, 2003.
13. ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology, IFPMA: Geneva, 2005.
14. ICH. Stability Testing: Photostability Testing of New Drug Substances and Products. International Conference on Harmonization. Geneva, November, 1996. IFPMA: Geneva.
15. Singh, S.; Bakshi, M. Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs Pharm. Tech. 2000, 24, 1-14.
16. Anderson, N. H. Photostability Testing: Design and Interpretation of Tests on Drug Substances and Dosage Forms, Taylor and Francis: London, 1996.
17. ICH. Stability Testing of New Drug Substances and Products. International Conference on Harmonization. IFPMA: Geneva, 1993.
18. ICH. Impurities in New Drug Products. International Conference on Harmonization. IFPMA: Geneva, 1996.
19. ICH. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. International Conference on Harmonization. IFPMA: Geneva, 1999.
20. ICH. Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. International Conference on Harmonization. IFPMA: Geneva, 1995.
21. Singh, S.; Garg, S. Analytical Method Validation. Pharma Times 1999, 15-20.
22. ICH. Text on Validation of Analytical Procedures. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use. IFPMA: Geneva, 2000.
23. Hong, D. D.; Shah, M. Development and Validation of HPLC Stability-Indicating Assays. Drug Stability: Principles and Practices, Marcel Dekker: New York, 2000; 329-384.