Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ESOMEPRAZOLE AND ITOPRIDE BULK AND ITS PHARMACEUTICAL FORMULATION

K. Kalyan Chakravarthi*, K. Venkataramana and K. Hima Bindu

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Abstract

A Simple, Precise, Accurate and rapid liquid chromatography (RPHPLC) method has been developed for the determination of esomeprazole and itopride in bulk and in tablet dosage form. A reverse phase Eclipse plus C18 column (250mmX4.6mm, 3μm) with mobile phase consisting of Buffer (3.85% Ammonium acetate in water), Methanol and Acetonitrile were added in the ratio of 30:40:30 and the pH was 5.The flow rate was 1.0 ml and effluents were monitored at 214nm. The Retention time of Esomeprazole was 4.55/min and Itopride was2.84/ min. The method was linear over the concentration range of 24, 32, 40, 48, 56 μg / ml for Esomeprazole and 90, 120,150, 180, 210 μg / ml for Itopride. The percentage mean recovery for 98.57% for Esomeprazole and 99.61% for Itopride and the RSD was observed under 1%. The method was carried out based on International Conference on Harmonization (ICH) guidelines. The proposed technique was a new method of analysis for assessment of Esomeprazole and Itopride drug substance by RPHPLC method. And the method was observed to be appropriate for the standard examination of esomeprazole and itopride in pure drug substance.

Keywords: Esomeprazole, Itopride, Acetonitrile, Methanol, validation, RP-HPLC.