RP-UPLC METHOD FOR COMBINATIONAL ASSAY OF LORNOXICAM AND PARACETAMOL IN COMBINED TABLET DOSAGE FORMAbstract
A simple, precise and stability-indicating ultra-performance liquid chromatography (UPLC) method for simultaneous determination of Paracetamol (PCM) and Lornoxicam (LOR) in tablet formulations has been developed and validated. The UPLC separation was achieved on a Waters Acquity UPLC BEH shield RPC18 (2.1x50mm, 1.7µm) column using acetonitrile:30mM Ammonium acetate (40:50, v/v) as mobile phase at a flow rate of 0.5mL/min. The eluted compounds were monitored at 260nm, the run time was within 5.0min, which PCM and LOR and its impurities were well separated. Quantitation was achieved over the wide concentration range 0.5-150μg/mL and 10-48μg/mL with mean recovery of 100.97 ± 0.31% and 99.73 ± 0.71% for PCM and LOR, respectively. Linear regression analysis revealed linearity in the range of 0.5-150µg/band and 10-48µg/band for PCM and LOR respectively. Drugs were subjected to the stress conditions of acid, alkali hydrolysis, oxidation for degradation. PCM was found to stable in base, acid, alkali, oxidative stress conditions and LOR was found to degraded significantly in base, and stable in acid/alkali, oxidative degradation conditions. The degradation products were well resolved from main peaks and its impurities, proving the stability indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.
Topalli Srinivasu *, B.N. Rao , M.M. Annapurna and T.G. Chandrashekhar
Sr. Research Scientist, Ranbaxy Research Laboratories Ltd., Plot No.20, Sector 18, Udyog vihar, Gurgaon, Haryana, India
21 December, 2011
10 January, 2012
23 March, 2012
01 April, 2012