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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR RELATED SUBSTANCES IN ESOMEPRAZOLE BY RP-HPLC IN SOLID DOSAGE FORM

Sandhya Mishra*, Disha kesharwani

A simple rapid, specific and selective reversed phase high performance liquid chromatographic (RP-HPLC) method for estimation of related substances in esomeprazole tablet was developed and validated. A gradient separation was achieved from Zorbax SB C-8, (150 x 4.6) mm, 5µm with mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution at a flow rate of 1ml/min with a UV detection at 280nm.The injection volume was 40µl.With stabilities studies for analytical solutions it was concluded that freshly prepared solution should be used for each injection. The method was specific as the peaks were homogeneous and there was no interference of Esomeprazole related substances with Esomeprazole peak and with each other. The Limit of Detection and Quantitation for all known related substances and Esomeprazole were within the limit. From the linearity studies, the correlation coefficient was found to be 0.990,which indicates that method was linear over 10% to 120%. The method was found to be precise and robust at each variable condition. Hence,the proposed method can be used for routine analysis of drug on account of related substances. Keywords: Esomeprazole, Method validation, Related substances, Proton pump inhibitor

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