Saturday , 20 April 2024

Method Development and Validation of Omeprazole by RP-HPLC Method in Bulk and Its Pharmaceutical Dosage Form

Nagadani Kalyani*, R. Kiran Jyothi, Dr. K.B Chandra Sekhar
Department of Pharmaceutical Analysis, JNTUA- Oil Technological and Pharmaceutical Research Institute, Ananthapuramu-515001, A. P, India

Omeprazole is a proton pump inhibitor ﴾PPI﴿ and a potent inhibitor of gastric acidity which is mostly used in the therapy of gastroesophageal reflux and peptic ulcer disease. It suppress the gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme Present research work was undertaken to develop and validate a simple, sensitive, rapid and selective isocratic reversed phase High Performance Liquid Chromatographic (HPLC) method has been developed for estimation of omeprazole from bulk drug dosage from using a mobile phase consisting mixture of phosphate Buffer (pH 3.6): acetonitrile ( 62:38v/v) Composition of buffer: (Dissolve 0.900gms of anhydrous disodium hydrogen phosphate and 1.298 gms of citric acid mono hydrate insufficient water to produce 1000ml) at the flow rate of 1mL/min using phenomenex C18 (250 cm x 4.6 mm, 5 μm) column as stationary phase. The retention time of omeprazole found to be 3.19 min. The eluent was detected at 301 nm. Linearity was observed in the concentration range of 25-150%level for omeprazole. Percent recoveries obtained for omeprazole were 100.28 % . The correlation coefficient for omeprazole was found to be 0.999. After performing analysis by different analysts, it was found that the RP-HPLC method for the determination of omeprazole was found to be Rugged. Percent RSD for robustness was well within the acceptable USP limits, ensuring that the proposed method was robust. For omeprazole the LOD were found to be 0.29899 µg/ml and the LOQ were found to be 0.93804 µg/ml. This demonstrated that the developed RP-HPLC method was simple, linear, precise, accurate, robust, and rugged, could be conveniently adopted for the routine quality control analysis of omeprazole, from its pharmaceutical formulations and bulk drug. Developed method was found to precise, accurate and validated as per pharmacopeial standard.
Keywords: Omeprazole, RP-HPLC, Development, Validation

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