"Stability-Indicating TLC–Densitometric Method for Simultaneous Determination of Paracetamol and Chlorzoxazone and their Toxic Impurities"

Research Abstract

A highly sensitive, selective and accurate thin- layer chromatographic TLC-densitometric method has been developed and validated for the simultaneous determination of Paracetamol (PAR), Chlorzoxazone (CZ) and their toxic impurities, 4-amino phenol (4AP) and 2-amino-4-chlorophenol (2ACP), respectively that are also considered to be the hydrolytic degradation products and related substances of the studied drugs. Developing system consisting of chloroform: methanol: glacial acetic acid (9.5: 0.5: 0.25, by volume) was found to be sufficient for good chromatographic separation among the four studied components using pre-activated silica gel 60 F254 TLC plates with UV detection at 225 nm. Calibration curves were constructed in the range of 0.3- 3, 1- 10, 0.06- 3 and 0.04- 3 µg/ band for PAR, CZ, 4AP and 2ACP, respectively using polynomial equations. The developed method was validated according to ICH guidelines and demonstrated good accuracy and precision. Moreover, the method was successfully applied for determination of PAR and CZ in different marketed samples and its results were statistically compared to those obtained by the reported RP-HPLC method using F and student's-t tests. The low detection and quantitation limits of the developed method make it suitable for quality control and stability studies of PAR and CZ in different pharmaceutical formulations

Research Keywords

paracetamol- chllorzoxazoneanla