title: Development and validation of an LC-ESI-MS/MS method for simultaneous quantitation of olmesartan and pioglitazone in rat plasma and its pharmacokinetic application.
abstract: 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.
authors.affiliation: Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700 032, India.
authors.forename: Pinaki
authors.initials: P
authors.lastname: Sengupta
authors.forename: Amlan Kanti
authors.initials: AK
authors.lastname: Sarkar
authors.forename: Uttam
authors.initials: U
authors.lastname: Bhaumik
authors.forename: Bappaditya
authors.initials: B
authors.lastname: Chatterjee
authors.forename: Bikash
authors.initials: B
authors.lastname: Roy
authors.forename: Uday Shankar
authors.initials: US
authors.lastname: Chakraborty
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Pal
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000097:blood* / Q000493:pharmacokinetics; D000818:Animals; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D007093:Imidazoles / Q000097:blood* / Q000493:pharmacokinetics; D008297:Male; D000077205:Pioglitazone; D051381:Rats; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013777:Tetrazoles / Q000097:blood* / Q000493:pharmacokinetics; D045162:Thiazolidinediones / Q000097:blood* / Q000493:pharmacokinetics
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D007093:Imidazoles; D013777:Tetrazoles; D045162:Thiazolidinediones; C437965:olmesartan; D000077205:Pioglitazone