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Development and validation of an LC‐ESI‐MS/MS method for simultaneous quantitation of olmesartan and pioglitazone in rat plasma and its pharmacokinetic application
Author(s) -
Sengupta Pinaki,
Sarkar Amlan Kanti,
Bhaumik Uttam,
Chatterjee Bappaditya,
Roy Bikash,
Chakraborty Uday Shankar,
Pal Tapan Kumar
Publication year - 2010
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1447
Subject(s) - chemistry , chromatography , olmesartan , pioglitazone , bioanalysis , analyte , electrospray ionization , formic acid , selected reaction monitoring , triple quadrupole mass spectrometer , pharmacokinetics , mass spectrometry , extraction (chemistry) , tandem mass spectrometry , pharmacology , medicine , blood pressure , type 2 diabetes , radiology , diabetes mellitus , endocrinology
A simple, high‐throughput and specific high‐performance liquid chromatography tandem mass spectrometry method has been developed and validated according to the FDA guidelines for simultaneous quantification of olmesartan and pioglitazone in rat plasma. The bioanalytical method consists of liquid–liquid extraction and quantitation by triple quadrupole mass spectrometry using electrospray ionization technique, operating in multiple reaction monitoring and positive ion modes. The compounds were eluted isocratically on a C 18 column with a mobile phase consisting of a mixture of methanol and water (containing 0.5% formic acid) in a ratio of 9:1. The response to olmesartan and pioglitazone was linear over the range 0.01–10 µg/mL. The validation results demonstrated that the method had satisfactory precision and accuracy across the calibration range. Intra‐ and inter‐day precisions ranged from 0.66 to 3.32 and from 0.94 to 2.93% (%CV), respectively. The accuracy determined at three quality control levels was within 91.27–107.28%. There was no evidence of instability of the analytes in rat plasma following the stability studies. The method proved highly reproducible and sensitive and was successfully applied in a pharmacokinetic study after single dose oral administration of olmesartan and pioglitazone to the rat. Copyright © 2010 John Wiley & Sons, Ltd.