DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HPLC METHOD FOR ESTIMATION OF KETOCONAZOLE IN BULK DRUG Rakesh Kumar Jat

A simple, accurate rapid and precise RP-HPLC method has been developed and validated for determination of ketoconazole in bulk drug. The RP-HPLC separation was achieved on Promosil C-18, (250 mm, 4.6 mm, 5µm) using mobile phase water: acetonitrile: buffer ph 6.8 (51:45:4 v/v) at flow rate of 1.0 ml/min at ambient temperature. The retention times were 2.713 min. for ketoconazole. Calibration plots were linear over the concentration range 1-50µg/ml. Quantification was achieved with photodiode array detection at 238 nm over the concentration range of 1-50 µg/ml. The method was validated statistically and applied successfully for the determination of ketoconazole. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of ketoconazole in bulk drug