Development and Validation of Rapid Resolution RP-HPLC Method for Simultaneous Determination of Atorvastatin and Related Compounds by Use of Chemometrics

REFERENCES

• Araujo , P.W. and Brereton , R.G. 1996 . Experimental design I. Screening . Trends Anal. Chem. , 15 : 26 – 31 .
   Web of Science ®Google Scholar
• Araujo , P.W. and Brereton , R.G. 1996 . Experimental design II. Optimization . Trends Anal. Chem. , 15 : 63 – 68 .
   Web of Science ®Google Scholar
• Budavari , S. 2001 . The Merck Index, an Encyclopedia of Chemicals, Drugs and Biologicals, , 13th ed . White House Station , New Jersey : Merck .
   Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Deming , S.N. and Morgan , S.L. 1993 . Experimental Design: A Chemometric Approach . Amsterdam : Elsevier .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Fabre , H. 1996 . Robustness testing in liquid chromatography and capillary electrophoresis . J. Pharm. Biomed. Anal. , 14 : 1125 – 1132 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Google Scholar
• 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 .
   Google Scholar
• 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 .
   Google Scholar
• Joseph , M. 2003 . High-throughput HPLC with short columns and n bub two-micron particles . Agilent Application Note , Publication Number 5988-9615EN .
   Google Scholar
• 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 .
   PubMedGoogle Scholar
• Lewis , G. A. , Mathieu , D. , and Phan-Tan-Luu , R. 1999. Pharmaceutical Experimental Design . New York : Marcel Decker.
   Google Scholar
• 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 .
   Google Scholar
• McEvoy , G.K. 2001 . American Hospital Formulary Service® . Bethesda : American Society of Health-System Pharmacists Inc .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Sweetman , S.C. 2005 Martindale: The Complete Drug Reference, , 34th ed . London : Pharmaceutical Press .
   Google Scholar
• Teva Drug master files . 2006 . htpp://www.betterchem.com/dmfs_select/teva.htm.
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• 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 .
   PubMedGoogle Scholar