Analytical method development and validation of gastrointestinal drug in bulk and pharmaceutical dosage form
Abstract
The present study involve the development and validation of a simple, accurate, precise, and robust by RP HighPerformance Liquid Chromatography (HPLC) these method use for the quantitative estimation of Fexuprazan Hydrochloride in bulk drug and pharmaceutical dosage forms. Various method were perform to validate the developed method various chromatographic condition are perform for the validation . Chromatographic separation was done by using a mobile phase consisting of methanol and 0.1% acetic acid in the ratio of 60:40 (% v/v), with detection perform at 220 nm.solubity study were perform optimization of HPLC are perform. The method demonstrated satisfactory chromatographic performance with good peak symmetry and acceptable retention characteristics. The developed method was validated according to the ICH guidelines. its involve the the graph result of validation parameter such as . The linearity, accuracy, precision Range, Specificity etc Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis Fexuprazan in bulk formulations. The developed RP-HPLC method for estimation of Fexuprazan is accurate
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