A new, simple, reliable and reproducible stability indicating RP-HPLC method simultaneous estimation of mifepristone and misoprostol in its oral solid dosage form. Effective chromatographic separations were achieved on a Hypersil C18, 250×4.6 mm, 5μ column with reverse phase elution. Methanol: Buffer (0.01M pentanesulfonic acid Sodium salt, pH 3.5 adjusted with OPA)(25:75v/v)as mobile phase and flow rate 1ml/min. Detection was carried out at wavelength 220nm. In Linearity was observed in the concentration rang 50-150µg/ml and 5-15µg/ml with correlation coefficient of mifepristone and misoprostol (R2) 0.998 and (R2) 0.997, respectively. The Mean recovery were found to be in the range 99.72-100.47% and 99.68 - 100.87%respectively. LOD and LOQ were found to be 1.297µg/ml and 3.931µg/ml for mifepristone and 0.0321 µg/ml and 0.0977µg/ml for misoprostol. The %RSD of repeatability precision, interday precision and intraday precision of mifepristone and misoprostol was found to be 0.9, 0.73 and 0.43 and 0.63, 0.74 and 1.03, respectively. It indicated that the method is precise. In forced degradation, the proposed method has been investigated with different stress conditions as hydrolytic, oxidative, thermal and Photo as recommended by ICH guidelines. An accurate and reliable RP-HPLC method for the analysis of mifepristone and misoprostol was developed and validated successfully.
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