HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHODOLOGY FOR BIFONAZOLE ESTIMATION: DEVELOPMENT AND VALIDATION INSIGHTS

The objective of the present study was to develop a simple, sensitive, specific and reliable high performance liquid chromatography method for the determination of Bifonazole (BFN) in pharmaceutical formulations.Separations were made by using C18-column (4.6 × 250mm i.d., particle size 5µm) HSS (High Strength Silica).The mobile phase used was a mixture of Acetonitrile: Water in the ratio of 70:30 v/v isocratic at 40º C. The mobile phase flow rate was 1mL/min with injection volume of 10µL.Sample detection was done by PDA detector at 254 nm with a retention time of 6.747 minute.Developed HPLC method was validated in compliance to ICH guideline Q2 (R1) and various validation parameters Specificity, Linearity, Accuracy, Precision, Limit of detection (LOD), Limit of quantification (LOQ), Robustness were determined.The developed method was independent of pH adjustment and use of buffers.The method was successfully employed in determination of BFN in pharmaceutical formulations and can be a speedy and cost-effective quality control means for routine quantitative analysis of BFN.