Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND PARACETAMOL IN BULK AND MARKETED FORMULATION BY VIERODT’S METHOD.

*Mahan M. Andhale, Kiran B. Erande and Ambadas R. Rote

ABSTRACT

Eperisone Hydrochloride (EPE) is a skeletal muscle relaxant and Paracetamol (PAR) is COX inhibitor. Their combination used as antispasmodics. A simple, specific, precise and accurate vierodt’s method was developed for simultaneous estimation of EPE and PAR in tablet dosage form with a dose of 50 mg for EPE and 325 mg PAR resp. λmax for EPE 261.88 nm and PAR is 243.77 nm. The linearity for EPE and PAR were in the range of 1-5 μg/mL and 2-10 μg/mL with y = 0.0541x + 0.0373, r2= 0.9964 for EPE and y = 0.0715x - 0.0058 r2= 0.9992 for PAR. The accuracy and reproducibility results are close to 100% with 2% RSD. Results of the analysis were validated statistically and found to be satisfactory. The results of proposed method have been validated as per ICH guidelines.

Keywords: Eperisone Hydrochloride, Paracetamol, vierodt’s method, ICH.