Abstract

VALIDATED HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF TOLPERISONE HYDROCHLORIDE AND PARACETAMOL IN TABLET DOSAGE FORM

*Mary Mathew, Shajahan Puthusseri

Abstract

A new, simple, precise and accurate HPTLC method was developed and validated for the simultaneous estimation of Tolperisone hydrochloride and Paracetamol in tablet dosage form. Chromatographic separation of the drugs were performed on aluminium plates precoated with silica gel 60 G F254 as the stationary phase and the mobile phase used was a mixture of Chloroform: Toluene: Methanol: Acetic acid (6.0: 3.0: 1.0: 0.5, v/v). Densitometric evaluation of the separated zones was performed using a UV detector at 254 nm in absorbance mode. The Rf values for Tolperisone hydrochloride and Paracetamol were found to be 0.65 0.01 and 0.47 0.01 respectively. The calibration curve was found to be linear between 200 to 1000 ng/spot for each of Tolperisone hydrochloride and Paracetamol. The accuracy and reliability of the method was assessed by linearity, precision (intraday % RSD and interday % RSD of Tolperisone hydrochloride and Paracetamol) and specificity in accordance with ICH guidelines. The limits of detection and quantification were found to be 60.02 ng/spot and 81.63 ng/spot for TOL, and 68.46 ng/spot and 92.72 ng/spot for PAR, respectively. The developed method can be successfully employed for the simultaneous determination of TOL and PAR in marketed tablet formulation.

Keywords: Simultaneous estimation, Tolperisone hydrochloride (TOL), Paracetamol (PAR), High Performance Thin Layer Chromatography (HPTLC), Densitometry, Validation.