抽象的

Development and validation of a rapid HPLC method for the simultaneous estimation of nimesulide and tizanidine hydrochloride in pharmaceutical tablet dosage form

Nitin D.Rawool, A.Venkatchalam

The objective of the present study was to develop a simple, precise and accurate reversed-phase HPLC method and subsequent validation of the same as per the ICH guidelines. The present study deals with the estimation by RP HPLC of two different drug components nimesulide (NMS) and tizanidine hydrochloride (TZN) present in a tablet formulation. The chromatographic separation of NMS and TZN was done using phosphate buffer along with methanol as mobile phase, in the proportion of 50: 50. The separation is done on a C18 column and it is estimated at a ë max of 250 nmwith a flowrate of 1ml/min. The retention times were about 3.7 and 9.3 min for TZN and NMS respectively. The specificity for interference of any peak with main peak of interest is checked. The repeatability was checked by system precision with relative standard deviation less than 1% in all instances, along withmethod reproducibility for TZN and NMS. The linearity ranges froma 10.02 to 30.07mg/ml for TZN and 500.60 to 1501.80 mg/ml for NMS respectively. Correlation coefficients (r) of the regression equations were greater than 0.999 in all cases. The system suitability by precision is also checked to ensure that the analytical method is precise. The precision of the method was demonstrated using intra- and inter-day assay R.S.D. values which were less than 1%. The method was found to be accurate and precise for estimation of the two drugs simultaneously. According to the validation results, the proposed method was found to be specific, accurate, precise and rapid. Hence the same can be applied to the quantitative analysis of tablets containing NMS–TZN binary mixtures.