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Analytical method development & validation of Eperisone Hydrochloride and Diclofenac Sodium in Rapisone D SR Capsules by RP-HPLC

Alagar Raja. M , Godavari Swetha , David Banji , Selva Kumar.D , Vanitha .C


A simple, sensitive, rapid, accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed for the simultaneous quantitative determination of Diclofenac Sodium(DIC) & Eperisone Hydrochloride (EPE) in capsule dosage form and statistically validated as per ICH guidelines. The Chromatographic separation was carried out on a Thermo Hypersil C-8 column (250×4.6mm, 5μm) by gradient elution mode. The mobile phase consists of Methanol, Phosphate Buffer(0.1M, pH 6) and Acetonitrile in the ratio of 30:40:30 (v/v/v) pumped at a flow-rate of 1.0 mL/min. The PDA detector was employed at a wavelength of 261nm. The retention times of Diclofenac Sodium & Eperisone Hydrochloride were found to be 2.21 min and 3.6 min respectively. The calibration curves were linear in the range of 20- 80μg/mL & 30-120 μg/mL for DIC & EPE. The method is accurate with %w/w recoveries of 99.03% & 100.9 % for Diclofenac Sodium and Eperisone Hydrochloride respectively & the method is precise with % RSD < 2.The proposed method is rapid, simple and does not require any separation process and it has been successfully applied to the assay of pharmaceutical dosage form(RAPISONE D SR capsules).

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