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

Volumn 81, Issue 1, 2013, Pages 93-114

  Vukkum, Pallavi ^a,b   Moses Babu, J ^a   Muralikrishna, R ^b  

^a DR REDDY'S LABORATORIES LTD   (India)

^b ANDHRA UNIVERSITY   (India)

Author keywords

Atorvastatin calcium; Forced degradation; LC MS; RP HPLC; Stability indicating method; Validation

Indexed keywords

ATORVASTATIN;

ANALYTICAL PARAMETERS; ARTICLE; DRUG DEGRADATION; DRUG HYDROLYSIS; DRUG IMPURITY; DRUG OXIDATION; DRUG STABILITY; HEAT STRESS; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEARITY; MASS SPECTROMETRY; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; PHOTOLYSIS; REVERSED PHASE LIQUID CHROMATOGRAPHY; ROBUSTNESS; SPECIFICITY; SYSTEM SUITABILITY; VALIDATION PROCESS;

EID: 84875349573     PISSN: 00368709     EISSN: 22180532     Source Type: Journal    
DOI: 10.3797/scipharm.1208-06     Document Type: Article

References (20)

1. Sparks DL, Sabbagh MN. Atorvastatin therapy lowers circulating cholesterol but not free radical activity in advance of identifiable clinical benefit in the treatment of mild-to-moderate AD. Curr Alzheimer Res. 2005; 2: 343-353. http://dx.doi.org/10.2174/1567205054367900
2. Gee M, Hasson NK. Effects of a tablet-splitting program in patients taking HMG-CoA reductase inhibitors: analysis of clinical effects, patient satisfaction, compliance, and cost avoidance. J Manag Care Pharm. 2002; 8: 453-458. http://www.ncbi.nlm.nih.gov/pubmed/14613379
3. Castano G, Mas R. Comparison of the efficacy and tolerability of policosanol with atorvastatin in elderly patients with type II hypercholesterolaemia. Drugs Aging. 2003; 20: 153-163. http://dx.doi.org/10.2165/00002512-200320020-00006
4. Hermann M, Christensen H. Determination of Atorvastatin and Metabolites in Human Plasma with Solid Phase Extraction Followed by LC-Tandem MS. Anal Bioanal Chem. 2005; 382: 1242-1249. http://dx.doi.org/10.1007/s00216-005-3266-5
5. Ravi VB, Mullangi R, Inamadugu JK, Pilli NR, Gajula R, Ponneri V. Simultaneous determination of atorvastatin and niacin in human plasma by LC-MS/MS and its application to a human pharmacokinetic study. Biomed Chromatogr. 2012; 26: 1436-1443. http://dx.doi.org/10.1002/bmc.2715
6. Bullen WW, Miller RA. Development and validation of a high-performance liquid chromatography-tandem mass spectrometry assay for atorvastatin, ortho-hydroxyatorvastatin and para-hydroxyatorvastatin in human, dog and rat plasma. J Am Soc Mass Spectrom. 1999; 10: 55-66. http://dx.doi.org/10.1016/S1044-0305(98)00118-4
7. Borek-Dohalský V, Huclová J, Barrett B, Nemec B, Ulc I, Jelínek I. Validated HPLC-MS-MS method for simultaneous determination of atorvastatin and 2-hydroxyatorvastatin in human plasma-pharmacokinetic study. Anal Bioanal Chem. 2006; 386: 275-285. http://dx.doi.org/10.1007/s00216-006-0655-3
8. Miao X-S, Metcalfe CD. Determination of pharmaceuticals inaqueous samples using positive and negative voltage switching microbore liquid chromatography-electrospray ionization tandem mass spectrometry. J Mass Spectrom. 2003; 38: 27-34. http://dx.doi.org/10.1002/jms.394
9. Jemal M, Ouyang Z. Quantitation of the acid and lactone forms of atorvastatin and its biotransformation products in human serum by high-performance liquid chromatography with electrospray tandem mass spectrometry. Rapid Commun Mass Spectrom. 1999; 13: 1003-1015. http://dx.doi.org/10.1002/(SICI)1097-0231(19990615)13:11<1003::AID-RCM597>3.0.CO;2-L
10. Miao X-S, Metcalfe CD. Determination of cholesterol-lowering statin drugs in aqueous samples using liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr A. 2003; 998: 133-141. http://dx.doi.org/10.1016/S0021-9673(03)00645-9
11. Nigović B, Damić M. Analysis of Atorvastatin and Related Substances by MEKC. Chromatographia. 2009; 69: 1299-1305. http://dx.doi.org/10.1365/s10337-009-1049-4
12. Erk N. Extractive Spectrophotometric Determination of Atorvastatin in Bulk and Pharmaceutical Formulations. Anal Lett. 2003; 36: 2699-2711. http://dx.doi.org/10.1081/AL-120024645
13. Bahrami G, Mohammadi B, Mirzaeei S, Kiani A. Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection. J Chromatogr B. 2005; 826: 41-45. http://dx.doi.org/10.1016/j.jchromb.2005.08.008
14. Seshadri RK, Desai MM, Raghavaraju TV, Krishnan D, Rao DV, Chakravarthy IE. Simultaneous Quantitative Determination of Metoprolol, Atorvastatin and Ramipril in Capsules by a Validated Stability-Indicating RP-UPLC Method. Sci Pharm. 2010; 78: 821-834. http://dx.doi.org/10.3797/scipharm.1004-14
15. Shetty SK, Surendranath KV. Quantitative Application to a Polypill by the Development of Stability Indicating LC Method for the Simultaneous Estimation of Aspirin, Atorvastatin, Atenolol and Losartan Potassium. Am J Anal Chem. 2010; 1: 59-69. http://dx.doi.org/10.4236/ajac.2010.12008
16. Petkovska R, Cornett C, Dimitrovska A. Development and Validation of Rapid Resolution RP-HPLC Method for Simultaneous Determination of Atorvastatin and Related Compounds by Use of Chemometrics. Anal Lett. 2008; 41: 992-1009. http://dx.doi.org/10.1080/00032710801978566
17. Mohammadi A, Rezanour N, Ansari Dogaheh M, Ghorbani Bidkorbeh F, Hashem M, Walker RB. A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. J Chromatogr B. 2007; 846: 215-221. http://dx.doi.org/10.1016/j.jchromb.2006.09.007
18. International Conference on Harmonisation. ICH Q1A (R2), Stability Testing of New Drug Substances and Products, 2000.
19. International Conference on Harmonisation. ICH Q3A (R2) Current Step 4 Version, impurities in new drug substances, October 2006
20. International Conference on Harmonisation. ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology, November 2005.