Abstract

DEVELOPEMENT AND VALIDATION OF CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF ACECLOFENAC AND CYCLOBENZAPRINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Shweta D. Mevada*, Mona R. Patel and Dr. H. U. Patel

ABSTRACT

simple, accurate, precise RP-HPLC method has been developed and validated for the simultaneous estimation of Aceclofenac and Cyclobenzaprine hydrochloridre in the Pharmaceutical Dosage Form. Separation was performed on a column [Hypersil BDS C18 (250mm x 4.6 mm, 5μm) with 0.05 M KH2PO4 Buffer pH 5:Methanol (60:40v/v) as a mobile phase and flow rate was kept at 1ml/min. Good sensitivity was found with UV detection at 220 nm. After method development repeatability and linearity were investigated. Retention time was found to be 5.077 and 3.213 min respectively for Aceclofenac and Cyclobenzaprine hydrochloride. The method was validated over the analytical range from 20-60 μg/ml for ACE (r2=0.999) and 1.5-4.5μg/ml for CYCLO (r2=0.999). This method showed good reproducibility and recovery with %RSD in the desired range. The proposed method can be successfully applied for the routine analysis of both drugs in their combine dosage form.

Keywords: Aceclofenac (ACE), Cyclobenzaprine hydrochloride, RP-HPLC method, validation.