Analytical Method Development and Validation of Different Marketed Omperazole Tablets by LC-MS/MS

Abstract

A Simple, high speed, sensitive and suitable analytical method for validation of Omeprazole (OME) by liquid chromatography-Tandem mass spectrometric (LC-MS/MS) assay method has been developed for the determination of omeprazole (OME) in different marketed tablets. Loperamide (LOP) was used as an internal standard (IS). The standard solutions and samples from different marketed tablets of omeprazole were chromatographed using reverse phase high performance liquid chromatography (RP-HPLC). The MS/MS detection was set at mass transitions of 346.24/197.9 m/z for Omeprazole and 477.3/266.0 m/z for Loperamide (IS) in positive ion mode. The standard curve obtained for Omeprazole was linear (R2= 0.9994) over the concentration range of 15.25-3906.25pg/ml. The results of intra- and inter-day precision studies were all within the acceptable limits (Branch, 2005). The overall average recoveries of analytes and IS were found approximately between 99% and 103 %. The high throughput LC-MS/MS method was validated for an accuracy, precision, sensitivity, recovery, and calibration range. The method has been successfully applied to the evaluation of existing marketed tablets containing omeprazole.