ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF SULPHADAIZINE IN PHARMACEUTICAL DOSAGE FORM BY HPLC
Mr. Gurcharan Singh*, Mr. Surinder, Dr. Reeta Sethi, Dr. Abhishek Dwivedi, Mr. Sudeep Rathi
The present work takes into account the development of Reverse Phase High Performance Liquid Chromatography (HPLC) for simultaneous method estimation and validation of sulphadiazine in pharmaceutical tablet formulation. The expected separation and peak shapes were obtained on Phenomenex 250 mm x 4.6 mm (5 μm) RP-18 column at a 40˚ C using a mobile phase consisting of orthophosphoric acid buffer (OPA) of pH 3.0 + perchloric acid (HclO4): ACN (90-10) at flow rate of 1ml/min respectively. The eluent detection was carry out using UV-Visible detector at 269 nm. The retention time of sulphadiazine was 7.2 min. The method was validated for linearity, Accuracy, Precision and Robustness. Both intra-day and inter-day precision (in terms of % RSD) were lower than 2% and regression coefficient of linearity was found to be 0.9992. Specificity in terms of % RSD was found to be 0.031. This method was successfully applied for quantification of sulphadiazine in pharmaceutical formulation. The method can be employed for routine Quality Control Analysis.
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