Method Development and Validation for Estimation of Eperisone Hydrochloride as API and in Tablet Dosage Form by Two Spectroscopic Methods

Abstract

Two simple and sensitive spectrophotometric methods have been developed for the determination of eperisone hydrochloride based on its ability to be detected in UV region (Normal UV) and its oxidation using potassium permanganate in alkaline medium (kinetic spectroscopic). The detection was done at 261.40 nm and 603.5 nm. The different experimental parameters affecting the method development were studied and optimized. The initial rate and fixed time method were utilized to construct calibration graph, and 5 minutes and 3 minutes, respectively, were found suitable for the determination of the concentration of drug. Linearity was found over the concentration range of 2–20 μg/mL, 15–30 μg/mL, and 15–35 μg/mL by UV, initial rate, and fixed time methods, respectively. The results were validated as per the ICH guidelines. RSD values were found to be less than 2%. The methods were applied for estimation of eperisone hydrochloride in RAPISONE (Abbott, Maharashtra). The assay results were found to be 100.4% ± 0.08, 99.93% ± 0.05, and 99.41% ± 0.04 by UV, initial rate, and fixed time method, respectively. Statistical comparison of the proposed methods showed a good agreement indicating no significant difference in accuracy and precision, thus confirming the suitability of UV and kinetic method for the estimation of eperisone hydrochloride in bulk as well as in tablet dosage forms.