International Journal of Pharmaceutical Chemistry and Analysis


Stability indicating RP-HPLC method for determination of eperisone hydrochloride and diclofenac sodium in tablet dosage form


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Author Details: Krishna R. Gupta, Kiran Keche, Anvesha V. Ganorkar

Volume : 3

Issue : 4

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 205

Article End Page : 218


Abstract

A simple HPLC method has been developed and subsequently validated for the simultaneous determination of Eperisone hydrochloride and Diclofenac sodium. Optimum chromatographic separations among the eperisone, diclofenac sodium and stress-induced degradation products were achieved by using Waters -ODS 5 μ C18 column (250 X 4.6mm) as stationary phase with Acetonitrile and 0.05% TEA pH 3.5 (75:25% v/v) as mobile phase at a flow rate of 1.0 mL min with detection at 273 nm. ICH guidelines were used to validate the developed method. Linearity was established for Eperisone hydrochloride and Diclofenac sodium in the range of 15-75 µg/ml and 10-60 µg/ml, respectively. Eperisone hydrochloride and Diclofenac sodium were exposed to acid, base and neutral hydrolysis, oxidation and photolytic stress conditions and the stressed samples were analyzed by the proposed method. Also the kinetics of degraded sample was evaluated for all the hydrolytic conditions. As the proposed method could effectively separate the drug from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in combined dosage form.

Keywords:
Eperisone hydrochloride, Diclofenac sodium, Kinetics, Validation