References

1. Bansal S., DeStefano A., Key Elements of Bioanalytical Method Validation for Molecules, AAPS Journal, 2007; 9(1): E109-E114. 2. Singh U.K., Pandey S., Pandey P., Keshri P.K., Wal P., Research Reviews: Bioanalytical method development and validation. http://www.expresspharmaonline.com/20081231/research02.shtml 3. Shah V.P., The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation, AAPS Journal, Small

2007; 9(1): E43-E47. 4. Patil S., Bioanalytical Method Development And Validation:Guidelines, Latest Reviews, 2009, Volume 7, Issue 3. 5. Peters F.T., Review: Bioanalytical method validation How, how much and why, Department of Experimental and Clinical Toxicology, Institute of Experimental and Clinical Pharmacology and Toxicology, University of Saarland. 6. Lindsay S., High performance liquid chromatography, 2nd edition, page no. 1-10. 7. Chamberlain J., The analysis of drugs in biological fluids, 2nd edition, page no. 139-151. 8. Niessen W.M.A., Liquid chromatography-mass spectrometry, Volume 79, 2nd edition, revised and expanded, page no. 3-28. 9. Van Bramer S.E., An Introduction to Mass Spectrometry, Widener University, Department of Chemistry, revised: September 2, 1998. http://science.widener.edu/~svanbram 10. Dr. Ashcroft A.E., An Introduction to Mass Spectrometry, Astbury Centre for Structural and Molecular Biology, The University of Leeds. http/www. astbury.leeds.ac.uk 11. Boyd R.K., "Linked-scan techniques for MS/MS using tandem-in-space Mass Spectrometry Reviews, 1994, 13 (5-6): 359410. 12. Synder L.R., Kirkland J.J., Practical HPLC method development, John wiley and sons, 2nd edition, page no. 1-10, 100-140,174-203. 13. Venn R.F., Principles and practice of bioanalysis, page no. 36-38. 14. Christian G.D., Analytical chemistry, sixth edition, John wiley and sons, page no. 541544. instruments",

15. Food and Drug Administration, FDA, Guidance for Industry: Bioanalytical Method Validation, Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2001. 16. Kelley M., DeSilva B., Key Elements of Bioanalytical Method Validation for Macromolecules, AAPS Journal, 2007; 9(2): E156-E163. 17. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Workshop/Conference Report Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays, AAPS Journal, 2007; 9(1): E30-E42. 18. Lee J., Ma H., Specificity and Selectivity Evaluations of Ligand Binding Assay of Protein Therapeutics Against Concomitant Drugs and Related Endogenous Proteins, AAPS Journal, 2007; 9(2): E164-E170. 19. Hughes N.C., Wong E.Y., Fan J., Bajaj N., Determination of Carryover and Contamination for Mass SpectrometryBased Chromatographic Assays, AAPS Journal, 2007; 9(3): E353-E360. 20. Nowatzke W, Woolf E., Best Practices During Bioanalytical Method Validation for the Characterization of Assay Reagents and the Evaluation of Analyte Stability in Assay Standards, Quality Controls, and Study Samples, AAPS Journal, 2007; 9(2): E117-E122. 21. Takahashi M., Quantitative determination of clopidogrel active metabolite in human plasma by LC-MS/MS: Application to bioequivalence studies, Journal of Pharmaceutical and Biomedical Analysis, Volume 48, Issue 4, 11 March 2008, pages 1219-1224. 22. Vocilkova L, Determination of Clopidogrel by Chromatography, Current Pharmaceutical Analysis, 2009, 5, pages 424-431. 23. Patel NK., Development of liquid Chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS-MS) for the simultaneous estimation of Clopidogrel & its carboxylic acid metabolite in human plasma using Glimepiride as an internal standard. 24. Robinson A, Development of fast, sensitive and specific LC-MS/MS bioanalytical method for the determination of unchanged Clopidogrel in human plasma over the range of 10-12000pg/ml. 25. Silvestro L, Development and Validation of HPLC-MS/MS method to determine Clopidogrel in human plasma and use of incurred samples to test back conversion. 26. Raghunadha Reddy S, Development of a simple, sensitive and reliable method for simultaneous quantification of Clopidogrel and its metabolite in human plasma by using HTLCMS/MS.

27. Delavenne X, Development and Validation of an ultra-performance LCMS method for the quantification of clopidogrel active metabolite in human plasma, with clopidogrel D4 as internal standard. 28. Zou-Jun J, Development and Validation of a sensitive and specific liquid chromatography-tandem-mass spectrometry method for the simultaneous determination of clopidogrel and its carboxylic acid metabolite (SR26334) in human plasma using nateglinide and pioglitazone as internal standards. 29. Singh U K, ) Bioanalytical method development and validation The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval. 30. Petkovska R, Development and Validation of RP-HPLC method for the simultaneous determination of clopidogrel and four related compounds specified as impurities. 31. Pranay W, Bioanalytical Method Development Determination of Drugs in Biological Fluids. 32. Vinod P, History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation. 33. Marian K, Key Elements of Bioanalytical Method Validation for Macromolecules the Third American Association of Pharmaceutical Scientists/US Food and Drug Administration (FDA) Bioanalytical Workshop. 34. Erk N., Simultaneous determination of irbesartan and hydrochlorothiazide in human

plasma by liquid chromatography, Journal of Chromatography B, Volume 784, Issue 1, 25 January 2003, Pages 195-201. 35. Hillaert S., Optimization and validation of a micellar electrokinetic chromatographic method for the analysis of several angiotensin-II-receptor antagonists, Journal of Chromatography A, Volume 984, Issue 1, 10 January 2003, Pages 135-146. 36. Lusk H.R., Development and Validation of Bioanalytical LC-MS/MS Methods for Irbesartan, Valsartan and Losartan/Losartan Acid Metabolite in Human EDTA Plasma, MDS Pharma Services. 37. Sane R.T., Estimation of plasma irbesartan using HPTLC and HPLC, Indian drugs, volume 40, No. 2, 2003, pages 104-110. 38. Albero I., Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry, Journal of Pharmaceutical and Biomedical Analysis, Volume 29, Issues 1-2, 20 June 2002, Pages 299-305.

39. Hillaert S., Optimization and validation of a capillary zone electrophoretic method for the analysis of several angiotensin-II-receptor antagonists, Journal of Chromatography A, Volume 979, Issues 1-2, 6 December 2002, Pages 323-333. 40. Gonzalez L., Fast screening method for the determination of angiotensin II receptor antagonists in human plasma by high-performance liquid chromatography with fluorimetric detection, Journal of Chromatography A, Volume 949, Issues 1-2, 8 March 2002, Pages 49-60. 41. Tripathi K.D., Essential of Medical Pharmacology, Sixth Edition, Jaypee Brothers Medical publishers (P) Ltd, New Delhi, 2008, page no. 453-454. 42. http://www.rxlist.com/avapro-drug.htm 43. http://www.medicinenet.com/irbesartan-oral/page3.htm 44. http://www.healthscout.com/rxdetail/68/85/2/main.html 45. http://en.wikipedia.org/wiki/Irbesartan 46. http://www.drugs.com/avapro.html 47. http://www.drugbank.ca