Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BIFONAZOLE AND IT’S STABILITY STUDY BY USING SOPHISTICATED RP-HPLC METHOD

Santosh R. Prajapati*, Atul R. Nagar and Dr. Purnima D. Hamrapurkar

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Abstract

A simple precise and sensitive method has been developed and validated for the quantification of Bifonazole. The aim of the presented work was to develop a precise and accurate method. The column used was Haemochrom C18(150x4.6mm x5μ) and the mobile phase consisted of acetonitrile and 0.05% TFA (20:80) with a flow rate of 1ml/min. retention time was found to be 6.871minute, wavelength 256 nm detection was carried out using PDA detector. Linearity was studied in the range 10 μg/ml - 50 μg/ml with coefficient correlation R2=0.9991. The developed method was also evaluated for various system suitability parameters and validated for accuracy, precision, LOD, and LOQ. The Method was successfully applied for stability indicating assay for the estimation of Bifonazole ie. cream.

Keywords: Bifonazole, RP-HPLC, Validation, Column, Force Degradation.