Development and Validation of a LC-MS/MS Method to DetermineLansoprazole in Human Plasma

Abstract

A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for the determination of lansoprazole (LNZ) in human plasma. Pantaprazole was used as an internal standard (IS). Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Oasis HLB, Oasis Max, Varian Bond Elute Plexa, Orochem cartridges. The reconstituted samples were chromatographed on a thermo hypurity Advance, 50 X 4.6mm, 5 µ by using acetonitrile and 2 mM ammonium acetate solution(80:20 v/v) as the mobile phase at a flow rate of 1.0 mL/min. Detection was carried out LC-MS/MS (API 3000) in negative ion mode. The calibration curves obtained were linear (R 2 -0.999) over the concentration range of 4.50- 2800.00 ng/ml for lansaprazole. The results of the intra- and inter-day precision studies were well within the acceptable limits. The overall average recoveries of analyte and IS were found to be 92.10-99.11%. The analyte were found to be stable of stability study. Developed and validated analytical method was found to be simple, rapid, specific, sensitive, precise and cost effective than reported methods. The method has been successfully applied to the investigation of a preclinical pharmacokinetic study with desired precision and accuracy along with high throughput.