Development and Validation of Stability Indicating HPTLC Method for Estimation of Mifepristone
Objective: To develop and validate stability indicating HPTLC method for determination of Mifepristone. Methods: The chromatographic development of the drug was carried out on aluminum plates pre-coated with silica gel 60 F254 as stationary phase using Toluene: Ethyl Acetate (7:3 v/v) as mobile phase. Detection wavelength chosen was 302 nm. Result: The retention factor (Rf) for Mifepristone was found to be 0.47 ± 0.02. The drug was subjected to stress testing as per ICH Q1A(R2).There was no interference of any degradant at Rf of Mifepristone. The developed method was successfully validated according to ICH Q2R1 guidelines. The calibration curve was found to be linear over a range of 100 - 500 ng/ band. The accuracy of the method is indicated by good recovery in the range of 100.35 - 102.97% with less than 2% of RSD. The limit of detection and limit of quantification were found to be 4.73 and 14.35 ng/band respectively. Conclusion: A new simple, accurate, precise and specific stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Mifepristone in bulk and pharmaceutical dosage form without any interference from the excipients. The proposed method can be used for routine determination of Mifepristone as it offers several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps.