Quantization of Aceclofenac in Pharmaceutical Formulations by RP-HPLC

An isocratic reversed phase high-performance liquid chromatographic (HPLC) method with ultraviolet detection at 281 nm has been developed for the determination of aceclofenac in dosage formulation. Good chromatographic separation aceclofenac was achieved by using a stainless steel analytical column Inertsil ODS, C18, 250 x 4.6 mm, 5 μ. The system was operated at (30±2°C) using a mobile phase consisting of buffer: acetonitrile (600:400) at a flow rate of 1.5 ml/min. The calibration curve for aceclofenac was linear over the tested concentration range of 50%, 75%, 100%, 125% and 150% with reference to the label claim and a correlation coefficient of 1.00. The intra-and inter-run precision and accuracy results were 99.07 to 100.20 with the %RSD of 0.45% and tailings factor 1.16. The proposed method was validated for its selectivity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of aceclofenac in bulk drug as well as in formulation.