Abstract
Author(s): Nalini Yamsani, Shravani Adepu, Prathima Srinivas
A simple, economic, sensitive, precise, efficient and reproducible RP-HPLC method was developed and validated for the quantitative simultaneous estimation of Mifepristone and Misoprostol in their pharmaceutical dosage form. The proposed method utilizes SymmetryC8 (150×4.6mm, 5µm) column and the separation was achieved by using a mixture of 0.02M Potassium Di Hydrogen Orthophosphate+0.03M Di Potassium Hydrogen Orthophosphate pH was adjusted to 3.5 using H3PO4:Acetonitrile(60:40) as the mobile phase at a flow rate of 1.0mL/min and column temperature was maintained at 30°C. Quantitation was achieved with UV detection at 251nm. Retention time of Mifepristone and Misoprostol were found to be 5.547min and 2.971min respectively. The method was validated for specificity, linearity, precision, accuracy and robustness. Method is specific as no interference from the blank and excipients were observed at the Retention time of any of the active ingredients. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 200-1200μg/mL for Mifepristone and 0.2-1.20μg/mL for Misoprostol respectively. The Limit of Detection values for Mifepristone and Misoprostol were found to be 0.54µg/ml and 0.69µg/ml respectively. The Limit of Quantitation values for Mifepristone and Misoprostol were found to be 1.65µg/ml and 2.1µg/ml respectively. Percentage RSD of the Mifepristone and Misoprostol were found to be 0.16 and 0.212 respectively. Percentage Recovery was found to be 99.48% to 99.69% for Mifepristone and 99.70% to 99.99% for Misoprostol respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Mifepristone and Misoprostol bulk and in their pharmaceutical dosage form.
