Abstract:
A novel drug named Tiapride Hydrochloride is used in management of behavioral disorders and in treatment of dyskinesias. Four different simple, accurate, rapid, economical and reproducible spectroscopic methods namely Zero order, First derivative, Second derivative and Area Under Curve(AUC) spectroscopy have been developed and validated for estimation of Tiapride Hydrochloride in physical mixture using distilled water as a solvent according to ICH Guidelines Q2(R1). These methods obey Beer’s law in the range of 20-70 μg/ml for Tiapride Hydrochloride. Absorbance of each solution was measured at 287.20 nm for zero order spectrophotometry. First derivative spectra are obtained by transformations at Δλ of 4 nm and scaling factor 1 and absorbance measured at 301.40 nm. Second derivative spectra are obtained by transformations at Δλ of 8 nm and scaling factor 10 and absorbance measured at 307 nm. Peak area is measured between 280.20-294.20 nm for AUC method. The methods showed good reproducibility and recovery with %RSD less than 1. All these four methods were compared statistically. Statistical comparisons by one way ANOVA shows all methods have equal applicability for estimation of Tiapride Hydrochloride in physical mixture. So, the proposed methods were found to be simple, specific, accurate, precise, linear and robust. Hence, all four methods can be equally applied for routine analysis of Tiapride Hydrochloride in pharmaceutical formulations.
