METHOD DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHODS FOR VALSARTAN IN BULK AND PHARMACEUTICAL FORMULATIONS USING UPLC TECHNIQUE
M. Purushothaman
S. Mohammed Yusuf
S. Mohammed Yusuf
A simple and selective UPLC method is described for the determination of VALSARTAN. Chromatographic separation was achieved on a Zorbax SB CN (50x2.0mm) 1.5µm column using mobile phase consisting of a mixture of 50 volumes of Phosphate Buffer, 50 volumes of Methanol with detection of 253 nm. The retention time was found to be 1.0503 min. Linearity was observed in the range 50-150 µg /ml for Valsartan (r2 =0.999). The amount of drug is estimated by the proposed methods was in good agreement with the label claim. The proposed method was validated. The accuracy of the method was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the method and can be used for routine analysis of pharmaceutical dosage form. All the analytical validation parameters were determined and found in the limit as per ICH guidelines.
8 , 2 , 2018
28 - 32
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