Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF FEXUPRAZAN HYDROCHLORIDE BY RP-HPLC IN BULK AND ITS TABLET DOSAGE FORM

Kshama Patel* and Dr. Vidhi Kotadiya

ABSTRACT

A RP-HPLC method was developed and validated to quantify the Fexuprazan Hydrochloride in bulk and its tablet dosage form. The chromatographic separation was carried out using a Waters Symmetry C18 (150 mm x 4.6 mm x 3 μ particle size) with a mobile phase consisting of buffer: methanol in a volumetric ratio of 20:80%. The UV wavelength chosen for detection was at 220 nm. The flow rate was set at 1.0 ml/min. The retention time for Fexuprazan Hydrochloride was determined to be 2.896 min. Linearity was detected within the concentration range of 20- 40 μg/ml for Fexuprazan Hydrochloride. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitablefor the routine analysis of Fexuprazan Hydrochloride in bulk and tablet dosage form.

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