DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HPLC METHOD FOR ESTIMATION OF HAMYCIN AND KETOCONAZOLE IN PHARMACEUTICAL CREAMAbstract
A simple, accurate rapid and precise RP-HPLC method has been developed and validated for determination of Hamycin and Ketoconazole in Pharmaceutical Cream. The RP-HPLC separation was achieved on Thermosil C-18, (250 mm, 4.6 mm, 5μm) using mobile phase 0.4 % ( v/v) diisopropylamine in methanol (v/v): 0.5% (w/v) Ammonium acetate in distilled water (90:10 % v/v) pH 6.5 adjusted with Glacial acetic acid at flow rate of 1.0 ml/min at ambient temperature. The retention times were 2.433 min. for Hamycin and 4.711 min. for Ketoconazole. Calibration plots were linear over the concentration range 50-250 μg/ml for Hamycin and 200-1000 μg/ml. Quantification was achieved with UV detection at 263 nm over the Beer-Lambert’s range.The method was validated statistically and applied successfully for the determination of Hamycin and 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 Hamycin and Ketoconazole in pharmaceutical cream. The proposed method was validated as per the ICH and USP guidelines.
Sunil Kumar*, R.. Nanda , Pritam Kuttepali and S.K. Sharma
Quality Assurance Department, Uttaranchal Biotech Ltd. Jainagar-3, Dineshpur Road, Rudrapur (U.S. Nagar), Uttarakhand., India
28 August, 2013
15 October, 2013
26 December, 2013
01 January, 2014