Abstract

DEVELOPMENT AND VALIDATED STABILITY INDICATING RPHPLC METHOD FOR THE DETERMINATION OF PANTOPRAZOLE IN PURE FORM AND ITS TABLET DOSAGE FORM

Puppala Sindhu*, Dr. Gampa Vijayakumar, Ramya Sri Sura

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Pantoprazole, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6×250mm) 5μ column using a mixture of Methanol: TEA Buffer pH 4.0 (70:30 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 280nm. The retention time of the Pantoprazole was 2.302 ±0.02min respectively. The drugs were exposed to thermal, photolytic, acid, alkali, and oxidative stress and the stressed samples were analyzed by use of the proposed method & chromatograms from the stressed samples, obtained by use of the photodiode-array detector. The method produce linear responses in the concentration range of 10-50mg/ml of Pantoprazole. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Pantoprazole, RP-HPLC, validation.