METHOD DEVELOPMENT AND VALIDATION OF PHENYTOIN SODIUM IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
To establish a method and validation developed for the determination of Phenytoin sodium in its pure form as well as in tablet dosage form by reverse phase high-performance liquid chromatographic method. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5 ïm) column using a mixture of m and phosphate buffer (60:40 v/v) as the mobile phase at a flow rate of 0.7 mL/min, the detection was carried out at 225nm. The retention time of the drug was 2.49±0.04 minutes. The method produced linear responses in the concentration range of 10 and 20mg/ml of Phenytoin sodium. The method precision for the determination of the assay was below 1.0%RSD. The method is useful in the quality control of Bulk and pharmaceutical formulations.