Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF ACECLOFENAC AND TIZANIDINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Neha M. Shinde, Padmanabh B. Deshpande*, Sonali D. Sangle, Vishal Tayde, Pawan Kudale

ABSTRACT

A simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic method has been developed and validated for simultaneous estimation of Aceclofenac and Tizanidine hydrochloride in combined tablet formulation. Chromatographic separation of both the drugs was achieved by using Toluene: Ethyl acetate: Methanol: Triethylamine (5: 3: 1: 0.5, v/v/v/v) as mobile phase with UV detection at 277 nm. The retention factors for Aceclofenac and Tizanidine hydrochloride were found to be 0.30 ± 0.005 and 0.73 ± 0.008, respectively. Stability of both drugs was accessed by subjecting the drugs to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. The developed method was validated in terms of linearity, accuracy, precision and robustness as per ICH guidelines. Linear response was observed in the concentration range of 1000-3500 ng band-1 for Aceclofenac and 20-120 ng band-1 for Tizanidine hydrochloride. The method has been applied successfully for the analysis of drugs in their combined tablet dosage form. The % assay (Mean ± S.D.) was found to be 99.95±0.3for Aceclofenac and 100.95 ± 0.8 for Tizanidine hydrochloride. The developed method can be used for the analysis of these drugs without any interference from the excipients and can be successfully used to estimate the amount of drugs in the formulations by easily available low cost materials.

Keywords: Aceclofenac, Tizanidine, HPTLC, Forced degradation, Tablet dosage form.


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