Reverse phase-high performance liquid chromatography (RP-HPLC) method have been developed and validated for the estimation of mifepristone and misoprostol. The developed method is rapid, accurate, precise, simple and specific. The separation was carried out using Hypersil C18 column (250 mm x 4.6 mm, 5µm i.d) as stationary phase in isocratic mode, with mobile phase containing Methanol: Buffer (0.01M Pentane sulphonic acid sodium salt pH 3.2 adjusted with OPA) (55:45v/v). The flow rate is 1 ml/min; detection was carried out at wavelength 220 nm. Chromatogram showed peak at a retention time of 2.750 min for mifepristone and 4.942 min for misoprostol. The method is validated for system suitability, linearity, precision, accuracy specificity, ruggedness, robustness, LOD and LOQ. Recovery of mifepristone and misoprostol is found to be in the range of 99.12 - 100.73% and 99.09 – 100.35%. LOD and LOQ were found to be 0.724 μg/ml and 2.196μg/ml for mifepristone respectively and 0.032μg/ml and 0.097 μg/ml for misoprostol respectively. Proposed method can be successfully applied for routine analysis of mifepristone and misoprostol in its pharmaceutical dosage form.
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