ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR STABILITY INDICATING HPTLC METHOD FOR ASSAY OF STIRIPENTOL IN BULK AND DOSAGE FORM

Abstract

Introduction: This work is concerned with the stability-indicating method development and validation of Stiripentol in a bulk drug and formulation by high-performance thin-layer chromatographic method (HPTLC). Materials and Methods:The pre-coated silica gel 60 F254 aluminum plate was selected as the stationary phase, and the solvent system consisted of Ethyl acetate: Dichloromethane: Toluene (2:2:6 v/v) used as developing solvents. Analysis of Stiripentol was carried out at 301 nm with Stiripentol being detected at an R(f) of 0.63. The developed method was validated for linearity, accuracy, precision, limit of detection (LoD), limit of quantitation (LoQ), robustness parameters, and stability are determined by force degradation study. Results and Discussion: The correlation coefficient of Stiripentol was 0.994 observed. The calibration plot was linear between 50–300 ng/band, respectively. The average percentage recovery of Stiripentol was found to be 100.25 %. Intra and inter-day precision measured as %RSD was less than 2%. Hence stability study of Stiripentol, it was found to degrade in acidic condition(8.52% - 0.1N HCL for 30 minutes at room temperature), alkali condition(7.47%- 0.1 N NaOH for 30min at room temperature), Hydrolytic condition(4.73%– dist. Water for 30min at room temperature), thermal condition(7.69%-40°C for 30min ), oxidative condition(7.55% - 3% H2O2 for 30min at room temperature) and photolytic UV condition(7.54% -24hr UV radiation) respectively. Stiripentol was unstable in acidic condition and stable in normal dist. Water hydrolytic condition. Conclusion: The proposed method was found to be very sensitive and accurate for the determination of Stiripentol in bulk and formulation.