HPTLC Method Development and Validation for Analysis of Risperidone in Formulations, and In-Vitro Release Study

A new, simple, and rapid high-performance thin-layer chromatographic method has been established for quantitative analysis of risperidone. Chromatography was performed on silica gel 60 F-254 plates with methanol-ethyl acetate 8.0:2.0 (v/v) as mobile phase. Risperidone was quantified by densitometric analysis at 285 nm. The method gave compact bands for the drug (R-F 0.34 +/- 0.01). Linear regression analysis of calibration data revealed a good linear relationship (r(2) = 0.9996) between response and amount of risperidone in the range 100-600 ng per band. The method was validated for precision, recovery, repeatability, linearity, specificity, and robustness in accordance with ICH guidelines. The minimum detectable amount was 22.44 ng per band and the limit of quantification was 68.01 ng per band. Statistical analysis of the results showed the method enabled precise, accurate, reproducible, and selective analysis of risperidone. The method was successfully used for estimation of the equilibrium solubility of risperidone, and for quantification of risperidone as the bulk drug in a commercially available preparation, in in-house-developed mucoadhesive microemulsion formulations, and in solution.