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Liquid Chromatographic Estimation of Cyclobenzaprine Hydrochloride and Aceclofenac in Pharmaceutical Formulation

Roshni D Pate, Usmangani K Chhalotiya, Falgun A Mehta, Dima A Shah, and Kashyap K Bhatt

A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Cyclobenzaprine Hydrochloride and Aceclofenac both as a bulk drug and in formulation. The method employed Luna C18 column (250 x 4.6 mm id, 5 μm particle size) as the stationary phase while Methanol and 0.02 M KH2PO4 (75: 25 v/v, pH 3) was used as mobile phase. The Rt of Cyclobenzaprine Hydrochloride and Aceclofenac were observed to be 4.2 and 9 minutes, respectively. Analysis was carried out in absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for Cyclobenzaprine Hydrochloride and Aceclofenac over a concentration range of 0.01-20 μg/ml and 0.1-40 μg/ml respectively with correlation co-efficient of 0.9990 for Cyclobenzaprine Hydrochloride and 0.9990 for Aceclofenac. The LOQ was found to be 0.01 and 0.1 μg/ml respectively for Cyclobenzaprine Hydrochloride and Aceclofenac. The method was validated as per ICH guideline and it was found to be accurate, precise and robust. Marketed formulation was analyzed successfully.