Simultaneous Determination of Aceclofenac and Pregabalin in Combined Dosage form by using RP-HPLC Method

A simple, rapid reverse phase high performance liquid chromatographic method (RP- HPLC) has been developed and validated for simultaneous estimation of Aceclofenac and Pregabalin in tablet dosage form. Chromatographic separation was achieved C-18 (250 mm × 4.6 mm, 5.0μ) as stationary phase and mobile phase containing phosphate (pH adjusted to 5.0 ± 0.05 using NaOH.) Buffer: Acetonitrile (30:70 v/v) at flow rate of 1 ml/min using UV detection at 210 nm. The retention time for Aceclofenac and Pregabalin was found to be 3.177 and 5.530 min respectively. The method was validated as per International Conference on Harmonization guideline and successfully used for the quantitative analysis of commercially available tablet. The calibration curve was linear over the concentration range of 20-60μg/ml for Aceclofenac and 15-45μg/ml for Pregabalin.. Lower values of Limit of Detection (0.60μg/ml for Aceclofenac and 0.88μg/ml for Pregabalin) and Limit of Quantification (1.84μg/ml for Aceclofenac and 2.68μg/ml for Pregabalin ) indicated good sensitivity of the method. The method was validate with respect to linearity, robustness, precision and accuracy and was successfully applied for the simultaneous determination of aceclofenac and pregabalin from the combined dosage formulation. The percent amount for both the drugs were found to be within limits in the tablet dosage form for both the methods.