Abstract
A stability-indicating high performance liquid chromatographic method was developed and validated for quantitative determination of Nimesulide and Chlorzoxazone in tablet dosage form. Isocratic high performance liquid chromatographic method, using a ECO C8 - (150mm*4.6mm*5μ) (particle size) as stationary phase with mobile phase Methanol: Acetonitrile: 1% Ammonium acetate (25:25:50%v/v/v) with flow rate of 1 ml/min retention time for Nimesulide and Chlorzoxazone were found to be 11.646min and 6.223min respectively. Nimesulide and Chlorzoxazone were exposed to acid/base hydrolytic, oxidative, thermal and photolytic stress conditions, and stressed sample were analysed by proposed method. There were no other co-eluting, interfering peaks from excipients, impurities or degradation products due to variable stress conditions. The linearity was obtained in the concentration range of 100-300 μg/ml for Nimesulide and 250-750 μg/ml for Chlorzoxazone. Limit of detection was found to be 4.71 μg/ml and 29.870 μg/ml and data for limit of quantification were found to be 14.273 μg/ml and 90.517 μg/ml for Nimesulide and Chlorzoxazone respectively. The mean recoveries were 102.36% and 102.07% for Nimesulide and Chlorzoxazone, respectively. The accuracy of the method was in compliance with the proposed limits and the precision of the method was satisfactory. The system suitability of the method showed that the performance of the chromatographic system is not significantly influenced by variations of the operational parameters inside an accepted domain. The excellent separation was demonstrated in the chromatograms and no interfering peaks were observed. Hence, the present method was found to be sensitive, rapid, specific, accurate and robust.
