A specific, accurate and precise stability indicating high-performance thin layer chromatographic method for estimation of flupirtine maleate in pharmaceutical formulation was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of ethyl acetate: chloroform: ammonia (25%); (9.0:1.0:0.2 v/v/v) which gave compact and dense spots for flupirtine maleate (Rf: 0.67±0.02). Densitometric analysis of drug was carried out in the reflectance-absorbance mode at 320 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2 = 0.9976 in the concentration range 100-500 ng/spot for flupirtine maleate. The method was validated with respect to linearity, specificity, accuracy, precision, limit of detection and limit of quantitation. The drug was subjected to acidic, alkaline, water hydrolysis, oxidation, thermal stress and photo degradation studies. The method could effectively separate the drug in presence of its degradation products and can be applied for analysis of pharmaceutical formulation of flupirtine.
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