Estimation of Centrally Acting Muscle Relaxant Drug Tolperisone Hydrochloride Using HPTLC Method

Abstract

A sensitive, selective and precise high performance thin layer chromatographic method has been developed and validated for the determination of tolperisone hydrochloride in bulk drug and in formulation. The method employed HPTLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase while the solvent system was methanol: ethyl acetate (3:7, v/v). The Rf value of tolperisone hydrochloride was observed to be 0.50 ± 0.008. The densitometric analysis was carried out in absorbance mode at 261nm. The linear regression analysis data for the calibration plots showed a good linear relationship for tolperisone hydrochloride over a concentration range of 50 - 800 ng/spot. The limit of detection and limit of quantification for tolperisone hydrochloride was found to be 7.57 and 10ng/spot. Tolperisone hydrochloride was subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation and sun light degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were assayed using developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of tolperisone in tablet dosage forms. The proposed study describes a HPTLC method for the estimation of tolperisone in bulk and their pharmaceutical dosage form. Statistical analysis showed that the method is suitable for the routine analysis of tolperisone in tablets.