Bio-analytical Method Development and Validation for Omeprazole Using Lc-ms/ms

Analytical methods employed for the determination of drugs and metabolites in biological matrices such as urine, plasma and serum are essential throughout drug discovery and development. It is well-known that, analytical techniques are constantly undergoing change and improvements and each analytical method has its own characteristics which may vary from analyte to analyte at different conditions. As the drug continues through development, the decisions become more critical; therefore, the bioanalytical methods that produce the data should be accurate. In the present study, we have developed a simple, precise and reproducible liquid chromatography tandem mass spectrometry method and validated according to FDA-GLP guidelines for quantification of Omeprazole in human plasma using Lansoprazole as internal standard utilizing LC-MS/MS incorporated with quadrapole mass spectrometer utilizing electrospray ionization technique. Samples were analyzed for Accuracy, Precision, Sensitivity, Selectivity, Recovery, stability and accuracy of method by injecting spiked matrix (human plasma) in to LC-MS/MS. The method specificity was determined by analyzing six different batches of human plasma to check the chromatographic conditions from endogenous plasma components. Sample recovery was determined at LLQQ, HQC, MQC and LQC levels using internal standard at single concentration. The objective of the present study is to determine the appropriateness of this method to omeprazole at different quantification level and keeping different criteria such as instrument stability, precision and accuracy, sample preparation strategies, calibration of instrument, recovery and matrix effect using omeprazole and the internal standard. INTRODUCTION: Bio-analytical methods involving rapid and sensitive analysis of drug substances in the matrix (body fluids) serve as an important tool in the evaluation, interpretation of clinical trial study results, drug discovery process 1, . According to FDA, the methods used in such analytical method should follow standard regulatory guidelines and the measurement of analyte in the biological matrix using a sophisticated instrument need to be validated and the procedure used for quantitative measurement of a analyte should be reliable and reproducible . Liquid chromatographymass spectrometry (LC-MS) in an analytical chemistry technique that combines the physical separation of a analyte (drug) and with the help of the mass analysis of drug (using mass spectrometry) is a very high