Author(s): Sumanta Mondal, Chanchala Alekya, and Prasenjit Mondal
Objectives: To Developed a novel, rapid, validated ultra-performance liquid chromatographic (UPLC) method for estimation of Ketoconazole in a bulk and tablet dosage form according to ICH Guidelines.
Methods: The chromatographic separation was achieved using Endoversil (50 x 2.1mm, 1.7μm) UPLC column. The mobile phase used was a mixture of Phosphate buffer pH 5.5: Methanol (40:60) at isocratic mode and eluents were monitored at 265 nm using PDA detector. Force degradation study was conducted for, acidic, alkaline, thermal, peroxide and photolytic conditions.
Results: By this method Ketoconazole was eluted with retention time of 0.520 min. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable and reproducible. Calibration curve plots were linear over the concentration ranges 8 to 32 μg/mL for Ketoconazole. Limit of detection (LOD) was 0.02μg/ml and limit of quantification (LOQ) was 0.06μg/mL for Ketoconazole.
Conclusion: The developed method was found suitable for the assay of ketoconazole in bulk and tablet dosage form.