DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRIC METHOD FOR SIMULTANEOUS QUANTIFICATION OF TELMISARTIN IN HUMAN PLASMA
Abstract
A simple, sensitive and selective method for the quantification of Telmisartan by using rapid high-performance liquid chromatography/positive electroscopy ionization tandem mass spectroscopy. The method consists of extraction with Acetonitrile followed by the analysis of the Extracted sample by liquid chromatography-mass spectroscopy (LC-MS/MS) in multiple reaction monitoring mode using electrospray ionization mode (ESI). Chromatography was performed on a C18 reverse phase column, Methanol: Acetonitrile: 10mM ammonium acetate (45:45:10) as a mobile phase. The assay exhibited a linear dynamic range of 10 to 700ng/ml for Telmisartan in human plasma. Stability assessment was also included. A run time of 2.5 min for each sample made it possible to analyse healthy volunteers participating in pharmacokinetics drug-drug interaction studies.
Keywords:
LC-MS/MS, Human Plasma, Telmisartan, Validation, BioanalyticalDOI
https://doi.org/10.25004/IJPSDR.2010.020305References
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2. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84: 9-15.
3. Willenheimer R, Dahl B, Rydberg E, Erhardt L. Angiotensin II receptor antagonists. Eur Heart J. 1999; 20:997-1008.
4. Ebner T, Heinzel G, Prox A, Beschke K, Wachsmuth H. Disposition and Chemical Stability of Telmisartan 1-O-Acylglucuronide. Drug Metab Dispos. 1999; 27: 1143-1149.
5. Gonzalez L, Akesolo U, Jimenez RM, Alonso RM. Determination of telmisartan in human blood plasma Part II: Liquid chromatography-tandem mass spectrometry method development, Comparison to immunoassay and pharmacokinetic study. Analytica Chimica Acta 2006; 560:41-49.
6. Torrealday N, Gonzalez L, Alonso RM, Jimenez RM, Lastra EO. Determination of telmisartan in human blood plasma. J Pharm Biomed Anal. 2003; 32:847-857.
7. Maotian TX, Song JF, Li N. Determination of telmisartan in human blood plasma. Anal Bioanal Chem. 2003; 377:1184-1189.
8. Maotian TX, Song J, Liang Y. Determination of telmisartan in human blood plasma. J Pharm Biomed Anal. 2004; 34:681–687.
9. Kondo T, Yoshida K, Yoshimura Y, Motohashi M, Tanayama S. Characterization of Conjugated Metabolites of a New Angiotensin II Receptor Antagonist, Candesartan Cilexetil, in Rats by Liquid Chromatography/Electrospray Tandem Mass Spectrometry Following Chemical Derivatization. J Mass Spec. 1996; 31:873–878.
10. Chen B, Liang Y, Wang Y, Deng FL, Zhou P, Guo F, Huang L. Determination of telmisartan in human blood plasma: Part I: Immunoassay development. Anal Chim Acta. 2005; 540: 367–373.
11. Yan T, Li H, Deng L, Guo Y, Yu W, Fawcett JP, Zhang D, Cui Y, Gu J. Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma. J Pharm Biomed Anal. 2008; 48: 1225-9.
12. Ferreiros N, Dresen S, Alonso RM, Weinmann W. Validated quantitation of angiotensin II receptor antagonists (ARA-II) in human plasma by liquid-chromatography-tandem mass spectrometry using minimum sample clean-up and investigation of ion suppression. Ther Drug Monit. 2007; 29: 824-34.
13. Zhang P, Zhang Y, Chen X, Li R, Yin J, Zhong D. Pharmacokinetics of telmisartan in healthy Chinese subjects after oral administration of two dosage levels. Arzneimittelforschung. 2006; 56: 569-73.
14. Li P, Wang Y, Wang Y, Tang Y, Fawcett JP, Cui Y, Gu J. Determination of telmisartan in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2005; 828: 126-9.
15. Krupadanam G L D, Vijaya Prasad D, Varaprasad Rao K, Reddy K L N, Sudhakar C. Analytical Chemistry. Orient Longman. 2005.
16. Chatwal anand. High performance liquid chromatography and column chromatography. Instrumental analysis. 2004.
17. Lloyd R Snyder, Joseph J, Kirkland Joseph, Glash, Chatwal anand. Mass spectrometry Practical HPLC method development. Instrumental analysis. 2007.
18. Murray R. Spiegel. Curve fitting. Regression and Correlation. Probability and Statistics. 2005.
19. Guidance for Industry: Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation; Draft Guidance. Rockville, MD. US FDA. 2000.
20. Guidance for industry. Bioanalytical method validation. US department of health and human services. Food and drug administration. May 2000.
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01-07-2010
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“DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRIC METHOD FOR SIMULTANEOUS QUANTIFICATION OF TELMISARTIN IN HUMAN PLASMA”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 2, no. 3, July 2010, pp. 188-92, https://doi.org/10.25004/IJPSDR.2010.020305.
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Copyright (c) 2010 Raghunadha Reddy Seelam, Sarath Chandiran I, Koteswara Rao Divi, Jayaveera K. N.
This work is licensed under a Creative Commons Attribution 4.0 International License.
How to Cite
“DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRIC METHOD FOR SIMULTANEOUS QUANTIFICATION OF TELMISARTIN IN HUMAN PLASMA”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 2, no. 3, July 2010, pp. 188-92, https://doi.org/10.25004/IJPSDR.2010.020305.
