Stability-Indicating HPTLC Method for Analysis of Tolterodine in the Bulk Drug

A simple, selective, precise, stability-indicating HPTLC method has been established for analysis of tolterodine in the bulk drug. Chromatography on aluminum foil-backed silica gel 60GF-254 plates with toluene-methanol-aqueous ammonia 5:5:0.02 (v/v) as mobile phase gave a compact spot at R(F) 0.40 +/- 0.02. Densitometric analysis of tolterodine was performed in absorbance mode at 284 nm. Linear regression analysis of the calibration data revealed a good linear relationship (r(2) > 0.990) between peak area and concentration in the range 200-1800 ng per band. The method was validated for accuracy, precision, linearity, limits of detection and quantification, and robustness. The limits of detection and quantification were 100 and 200 ng per band, respectively. Tolterodine was subjected to forced degradation and results showed the molecule undergoes degradation under basic conditions. Statistical analysis proved the method enables precise, selective, and accurate analysis of tolterodine. The method can be used for identification and quantitative analysis of tolterodine in the bulk drug.