Method Development for 4-Hydroxy-2-Methyl-N- (5-Methyl-2-Thiazolyl)-2H-1,2-Benzothiazine-3-Carboxamide-1,1-Dioxide by Reverse Phase HPLC: New Analytical Technique

Abstract

Purpose: In this study, development of a new analytical method for the evaluation of 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide (Meloxicam) by reverse phase HPLC was carried out. The basic aim of this research was to develop and validate a simple, precise, accurate and sensitive method for qualitative and quantitative analysis of Meloxicam in pharmaceutical raw material and its dosage forms. The existing reported method (BP) for the analysis of Meloxicam is potentiometric method which is an old, lengthy and tedious method. Methods: In the new method of reverse phase HPLC, C18 column was used while the mobile phase was acetonitrile and methanol (70:30). The flow rate of mobile phase was 0.6 ml/min and retention time was found to be 1.5min. Separately equal volume of standard solution and sample solutions in HPLC vials were injected in auto sampler compartment of HPLC in six replicates. Chromatogram and peak areas of Meloxicam in standard and sample solutions of different concentrations were recorded. Results: This method was later validated in different ways by which the calibration curve proved to be linear with linearity coefficient of 0.999 over the range of 100 to 600ppm. The precision was equivalent to 0.0003%. The LOD and LOQ were 0.0003ug/ml and 0.001ug/ml respectively. The system also showed accuracy over the range of 95 to 99%. Conclusion: Hence, this method proved to be an alternative to the existing reported method of potentiometric titration because the new method showed accuracy, reproducibility and sensitivity.