Author(s): Pritam S. Jain, Devendra S. Girase, and Jineetkumar B. Gawad*
A rapid and reproducible stability indicating TLC-densitometric method was developed for the determination of eperisone hydrochloride and paracetamol in presence of their degraded products in bulk drugs and pharmaceutical formulations. Uniform degradation conditions were maintained by refluxing reaction mixtures for 8 h at 60°C including acidic, alkaline hydrolysis. Oxidation at room temperature, photochemical and dry heating degradation studies were also carried out. A sensitive and robust stability indicating TLC-densitometric method for simultaneous quantification of eperisone hydrochloride and paracetamol in bulk drugs and pharmaceutical formulations has been developed and validated. Separation was done on TLC aluminum sheets, pre-coated with silica gel 60F-254 using ethyl acetate: toluene: methanol (2:2:1 v/v/v). Spots at Rf 0.42 ± 0.04 and Rf 0.60 ± 0.02 were recognized as paracetamol and eperisone hydrochloride, respectively. Densitometric analysis of chromatoplates was carried out in absorbance mode at isobastic point 260 nm. The developed method was optimized and validated as per ICH guidelines. Method was found linear over the concentration range of 100-350 ng / spot for eperisone hydrochloride and 600-2100 ng / spot for paracetamol with the correlation coefficient (r2 ) of 0.999 and 0.999 for eperisone hydrochloride and paracetamol, respectively. The developed TLC method can be applied for routine analysis of eperisone hydrochloride and paracetamol in presence of their degraded products in their combined pharmaceutical formulations.