Development and Validation of RP-HPLC Method for Simultaneous Determination of Diclofenac Sodium and Eperisone Hydrochloride in Pharmaceutical Dosage Form

Abstract

1. Abstract: A new, simple, precise, accurate and selective high performance thin-layer chromatographic (HPTLC) method has been developed and validated for the simultaneous determination of Tolperisone hydrochloride and Diclofenac sodium in a tablet dosage form. Chromatographicseparation was carried out on Merck TLC aluminium sheets of silica gel 60F 254 using Toluene: Ethyl acetate: Methanol (4: 4: 2 ml (v/v/v)) as mobile phase followed by densitometric analysis at 282 nm. The reliability of the method was assessed by evaluation of linearity (120-720 ng/spot forTolperisone hydrochloride and 40-240 ng/spot for Diclofenac sodium), accuracy (99.65 % for Tolperisone hydrochloride and 100.75 % for Diclofenac sodium), precision, repeatability and specificity, in accordance with International Conference on Harmonization (ICH) guidelines. Statistical analysis of the datarevealed that the method is precise, accurate, reproducible, sensitive and selective. The method can be successfully employed for the simultaneous determination of Tolperisone hydrochloride and Diclofenac sodium in pharmaceutical formulation.