Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ACECLOFENAC AND CYCLOBENZAPRINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Bhumika K. Patel*, Ankit B. Chaudhary, Shweta M. Bhadani and Bhoomi D. Patel

ABSTRACT

A simple, precise and accurate stability indicating RP-HPLC method has been developed and subsequently validated for the simultaneous estimation of Aceclofenac and Cyclobenzaprine Hydrochloride. The separation was carried out using Inertsil ODS C18 column (250mm x 4.6mm, 5μm), mixture of 0.05 M Potassium dihydrogen phosphate (PH 5.0 ): Methanol:Trietylamine 70:30:01 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 210 nm using UV detector. The retention time of Cyclobenzaprine Hydrochloride and Aceclofenac were 3.200 min and 5.093 min respectively. The method is linear over the range of 1.5-4.5μg/ml and 20-60μg/ml for Cyclobenzaprine Hydrochloride and Aceclofenac respectively. The method was found to be precise, accurate and specific during the study. The percentage recoveries were found to be 99.140%-100.971% and 100.495%-101.487% for Cyclobenzaprine Hydrochloride and Aceclofenac respectively. Cyclobenzaprine Hydrochloride and Aceclofenac were subjected to stress condition to check the degradation behaviour of them. The drugs undergo degradation under acidic, basic, oxidative, thermal and photolytic condition. The proposed method enables rapid quantification and simultaneous analysis of both drugs from commercial formulations without any interference of excipients. So, the method can be used for routine analysis of Cyclobenzaprine Hydrochloride and Aceclofenac in combined tablet formulation.

Keywords: Cyclobenzaprine Hydrochloride and Aceclofenac, RP-HPLC, Stability indicating.