HPLC Method Development and Validation for Estimation of Eperisone Hydrochloride from Bulk and Marketed Formulation

Abstract

Rapid, accurate and precise method for identification and quantitation of Eperisone Hydrochloride (EPE) was developed by reversed-phase high performance liquid chromatographic (RP-HPLC) and validated. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method, Eperisone Hydrochloride shows the maximum absorbance at 255 nm. The Agilent HPLC 1200 series system, employed with software EZ Chrom Elite was used for proposed analytical work. Column chromatographic development was carried out with the help of reversed-phase mode using HiQSil C18 (4.6 mm X 250 mm, 5 mm i.d., 5 µm particle size). The optimized mobile phase consisted of Methanol: Double distilled water (pH maintain 3) (90:10 %v/v) as the mobile phase and detection wavelength of 255 nm.Flow rate was kept at 0.8 mL min-1. Drug- Eperisone Hydrochloride was well resolved and retained at 2.9 min. Performance characteristics of HPLC method for estimation of EPE in bulk and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. This method was validated for accuracy, precision, linearity, LOD & LOQ of sample solution.The HPLC method was found to be linear with R2 value of 0.9942 and across the range 10 µg/ml- 90 µg/ml. The LOD 0.645 μg/ml and LQD values were found to be 0.645 μg/ml and 1.957μg/ml respectively. The method was found to be accurate, precise, robust and economical for the analysis of EPE from bulk and its formulation. Thus this method can be safely and successful employed for analysis of routine samples and quality control of drugs in pharmaceutical formulations.