An-Najah Staff

The purpose of this study was to develop 1% Bifonazole (BF) powder formulation and to develop a stability indicating HPLC method for its analysis in raw materials and in its final dosage form according to the ICH (International Conference on Harmonization) guidelines. Materials and method: A powder formulation containing 1% w/w BF was developed. A gradient HPLC method was performed; the flow rate was 1 ml/min, injected volume 20μL, the mobile phase consisted of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 255nm. BF was exposed to thermal, oxidative, acid-base hydrolytic stress conditions followed by analysis of the stressed samples. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. Main findings: The developed method was specific for the estimation of BF in presence of its degradation products and impurities. The method was linear over the range of 0.024 to 0.056 mg/mL with coefficient of regression R2, value as 0.9998. The mean recoveries were 99.62%. The percentage of relative standard deviation (%RSD) was found to be less than critical value. This is a stability indicating, economical and easy method which is useful in the quality control of bifonazole in powder dosage forms.