Development and validation of rapid resolution RP-HPLC method for simultaneous determination of atorvastatin and related compounds by use of chemometrics

Analytical Letters

Volumn 41, Issue 6, 2008, Pages 992-1009

  Petkovska, R ^a   Cornett, C ^b   Dimitrovska, A ^a  

^a SS Cyril and Methodius University Faculty of Pharmacy   (Macedonia)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Atorvastatin; Experimental design; Impurities; Rapid Resolution RP HPLC; Validation

Indexed keywords

EID: 45849153132     PISSN: 00032719     EISSN: 1532236X     Source Type: Journal    
DOI: 10.1080/00032710801978566     Document Type: Article

References (26)

1. Araujo, P.W. and Brereton, R.G. 1996. Experimental design I. Screening. Trends Anal. Chem., 15: 26-31.
2. Araujo, P.W. and Brereton, R.G. 1996. Experimental design II. Optimization. Trends Anal. Chem., 15: 63-68.
3. Budavari, S. 2001. The Merck Index, an Encyclopedia of Chemicals, Drugs and Biologicals, 13th ed. White House Station, New Jersey: Merck.
4. Bylund, D., Bergens, A., and Jacobsson, S.P. 1997. Optimization of chromatographic separations by use of a chromatographic response function; Empirical modeling and multivariate analysis. Chromatographia, 44: 74-80.
5. Chaudhari, B.G., Patel, N.M., and Shah, P.B. 2007. Stability indicating RP-HPLC method for simultaneous determination of Atorvastatin and Amlodipine from their combination drug products. Chem.Pharm.Bull., 55: 241-246.
6. Deming, S.N. and Morgan, S.L. 1993. Experimental Design: A Chemometric Approach. Amsterdam: Elsevier.
7. Erturk, S., Akta, E.S., Ersoy, L., and Ficicioglu, S. 2003. An HPLC method for the determination of Atorvastatin and its impurities in bulk drug and tablets. J. Pharm. Biomed. Anal., 33: 1017-1023.
8. Fabre, H. 1996. Robustness testing in liquid chromatography and capillary electrophoresis. J. Pharm. Biomed. Anal., 14: 1125-1132.
9. Franck, M. 2006. Impurity profiling with the Agilent 1200 Series LC System, Part 3: Rapid condition scouting for method development. Agilent Application Note, Publication Number 5989-5619EN.
10. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2006. Topic Q3A(R2), Impurities in new drug substances. ICH Harmonised Tripartite Guideline: Impurities in New Drug Substances, Q3A(R1), Current version approved 25 October 2006.
11. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2006 Topic Q2(R1), Validation of analytical procedures: Text and methodology. ICH Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology, Q2(R1). Complementary Guideline on Methodology. Dated 6 November 1996, incorporated November 2005.
12. Joseph, M. 2003. High-throughput HPLC with short columns and n bub two-micron particles. Agilent Application Note, Publication Number 5988-9615EN.
13. Kanaka, R., Rayanakorn, M., Watanesk, S., and Vaneesorn, Y. 2002 Optimization of high-performance liquid chromatographic parameters for the determination of capsaicinoid compounds using the simplex method. Anal. Sci., 18: 661-665.
14. Lewis, G. A., Mathieu, D., and Phan-Tan-Luu, R. 1999. Pharmaceutical Experimental Design. New York: Marcel Decker.
15. Lundsted, T., Seifert, E., Abramo, L., Thelin, B., Nystorm, A., Pettersen, J., and Bergman, R. 1998. Experimental design and optimization. Chemom. Intell. Lab. Syst., 42: 3-40.
16. McEvoy, G.K. 2001. American Hospital Formulary Service®. Bethesda: American Society of Health-System Pharmacists Inc.
17. Miao, X. and Metcalfe, C.D. 2003. Determination of cholesterol-lowering statin drugs in aqueous samples using liquid chromatography-electro spray ionization tandem mass spectrometry. J. Chromatogr. A, 998: 133-141.
18. Mohammadi, A., Rezanour, N., Dogaheh, M.A., Bidkorbeh, F.G., Hashem, M., and Walker, R.B. 2007. A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. J. Chromatogr. B, 846: 215-221.
19. Posvar L., Radulovic, L.L., Cilla, D.D., Whitfield, L.R., and Sedman, A.J. 1996. Tolerance and pharmacokinetics of single-dose atorvastatin, a potent inhibitor of HMG-CoA reductase, in healthy subjects. J. Clin. Pharmacol., 36: 728-731.
20. Ragonese, R., Mulholland M., and Kalman, J. 2000. Full and fractionated experimental designs for robustness testing in the high-performance liquid chromatographic analysis of codeine phosphate, pseudoephedrine hydrochloride and chlorpheniramine maleate in a pharmaceutical preparation. J.Chromatogr. A, 870: 45-51.
21. Ramakrishna, N.V.S., Koteshwara, M., Vishwottam, K.N., Puran, S., Manoj, S., and Santosh, M. 2004. Simple, sensitive and rapid LC-MS/MS method for the quantization of cerivastatin in human plasma: Application to pharmacokinetic studies. J.Pharm. Biomed. Anal., 36: 505-515.
22. Sweetman, S.C. 2005 Martindale: The Complete Drug Reference, 34th ed. London: Pharmaceutical Press.
23. Teva Drug master files. 2006. htpp://www.betterchem.com/dmfs_select/teva. htm.
24. Toribio, L., del Nozal, M.J., Bernal, J.L., Alonso, C., and Jiménez, J.J. 2005. Comparative study of the enantioselective separation of several antiulcer drugs by high-performance liquid chromatography and supercritical fluid chromatography. J.Chromatogr. A, 1091: 118-123.
25. Witzum, J.L. 1996. Drugs used in the treatment of hyperlipoproteinemias, 9th ed. New York: McGraw Hill. Eds; Hardman, J.G., Limbird, L.E., and Molonoff, P.B.
26. Yasuda, N., Matzno, S., Iwano, C., Nishikata, M., and Matsuyama, K. 2005. Evaluation of apoptosis and necrosis induced by statins using fluorescence-enhanced flow cytometry. J. Pharm. Biomed. Anal., 39: 712-717.