Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE ASSESSMENT OF OMEPRAZOLE IN DELAYED-RELEASE TABLETS

Dr. S. Joshna Rani and Lohitha Lakshmi Adimulam*

ABSTRACT

The current study aims to create a new sensitive and selective high-performance liquid chromatography (HPLC) method for evaluating omeprazole in delayed-release tablets. Because it produces very effective separations and, in most situations, great detection sensitivity, RP-HPLC is a prominent separation technology in current pharmaceutical and biological analysis. The key benefit of RP-HPLC over other separation modalities is its high efficiency and ability to differentiate between chemically identical molecules. The antacid omeprazole analysis was performed utilizing a Shimadzu LC-10A system with an RP-C18 column and UV- visible detection at 280nm as delineated during this study. At a rate of 1.5ml/min, the mobile section was diluted with phosphate buffer(pH7.4) and acetonitrile(70:30 v/v). The developed RP-HPLC methodology for omeprazole(Prilosec) analysis was valid in keeping with the ICH (InternationalCouncill for technical needs for prescription drugs for human use) tips. The validated parameters are accuracy, precision, linearity, range, LOD&LOQ, and specificity. The devised method was determined to be satisfactory and adequate for omeprazole quality control in delayed-release tablets.

Keywords: Reversed-phase High-performance liquid chromatography(RP-HPLC), International conference on harmonization(ICH), method development, validation, omeprazole, biomedical analysis.