A Validated Reversed Phase-High Performance Liquid Chromatographic (RP-HPLC) Method for Simultaneous Estimation of Aceclofenac Drug Substance and Its Related Traces Impurities In The Solid Dosage Form

A reversed-phase high performance liquid chromatographic method is developed and validated for the simultaneous evaluation of aceclofenac and its related impurities in tablet dosage form. The chromatographic separation achieved on a C18 Inertsil reversed-phase column using an isocratic elution, being mobile phase acetonitrile: methanol: water (60:28:12) and pH of final mobile phase was adjusted to 7.0 with glacial acetic acid and sodium hydroxide. The limit of quantitation (S/N = 10:1) is in the range of 0.0138-0.370 μg/ml for each impurity. The coefficient of variations is less than 3% for intraday and variation in analysts. The recovery of aceclofenac spiked samples ranged from 99-102 % and the mean recovery for each level ranges from 99-101 % for the detected impurities. The related impurities (methyl and ethyl esters) are synthesized by refluxing acids in appropriate alcohol as described in the literature and used as a reference in analysis. Their structures are confirmed by spectral (IR, NMR, MASS) and elemental analysis while their purity confirmed by HPLC analysis. The proposed validated method is suitable for the analysis of different brands of aceclofenac tablets available in market, hence can be employed in the routine quality control analysis of aceclofenac and its solid dosage form.