Stability Indicating RP-HPLC Method by QbD Approach and LC-MS Characterization of Degradation Products of Mifepristone.

A Stability indicating revered phase high performance liquid chromatography (RP-HPLC) method have been developed and validated for the estimation of Mifepristone. LC-MS Studies was carried out for identification of possible degradation products. A simple, rapid, accurate and precise stability indicating RP-HPLC method was developed for quantification of Mifepristone. The developed method used the mixture of methanol and water (88:12 v/v) as mobile phase at flow rate of 1 ml /min, which was optimized with the help of Quality by Design approach. Detection was carried out at 305 mm. The linearity of the proposed method was found in the concentration range of 5-25 μg/ml with regression coefficient (R2) of 0.996. LOD and LOQ were found to be 0.0324 and 0.0982 μg/ml, respectively. The recovery of the proposed method was found to be 98%-100%. The method was found to be precise and robust. The developed stability indicating RP-HPLC method was successfully applied for quantification of Mifepristone in pharmaceutical dosage form. The degradation products were characterized by LC-MS and the fragmentation pathways were proposed.