Development and Validation of a Stability-Indicating LC Method for Simultaneous Analysis of Aceclofenac and Paracetamol in Conventional Tablets and in Microsphere Formulations

Research paper by Shahid Jamil, Sushma Talegaonkar, Roop K. Khar, Kanchan Kohli

Indexed on: 19 Sep '08Published on: 19 Sep '08Published in: Chromatographia


A stability-indicating reversed-phase LC method for analysis of aceclofenac and paracetamol in tablets and in microsphere formulations has been developed and validated. The mobile phase was 80:20 (v/v) methanol–phosphate buffer (10 mM at pH 2.5 ± 0.02). UV detection was at 276 nm. The method was linear over the concentration ranges 16–24 and 80–120 μg mL−1 for aceclofenac and paracetamol, respectively, with recovery in the range 100.9–102.22%. The limits of detection and quantitation for ACF were 0.0369 and 0.1120 μg mL−1, respectively; those for PCM were 0.0631 and 0.1911 μg mL−1, respectively.