Abstract

VALIDATED STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM IN COMBINED CAPSULE DOSAGE FORM

Mayur Mahire and Padmanabh Deshpande*

ABSTRACT

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for simultaneous estimation of Eperisone hydrochloride and Diclofenac sodium in combined capsule dosage form. The mobile phase selected was Toluene: Ethyl acetate: Methanol (7: 3: 1, v/v/v) with UV detection at 268 nm. The retention factors were found to be 0.25±0.04 and 0.59±0.07 for Eperisone hydrochloride and Diclofenac sodium, respectively. The method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 300-1800 ng band-1 and 200-1000 ng band-1 for Eperisone hydrochloride and Diclofenac sodium, respectively. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 99.50 ± 0.96 for Eperisone hydrochloride and 99.88 ± 1.10 for Diclofenac sodium. The developed and validated stability indicating method can be used for assessing the stability of Eperisone hydrochloride and Diclofenac sodium in bulk drug and in pharmaceutical dosage form.

Keywords: Eperisone, Diclofenac, Forced degradation, Capsule dosage form.