ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ESTIMATION OF RESIDUAL SOLVENTS IN PHENYTOIN SODIUM API BY HEAD SPACE GAS CHROMATOGRAPHY

To develop GC-HS method for analysis of Residual Solvents (ppm) in Phenytoin sodium sample as per the below specification. The developed Head Space Gas Chromatography (GC-HS) method for the analysis of Development and Validation of Estimation of Residual Solvents in Phenytoin sodium API is Precise and feasible. The separation was carried out on the DB-624 Column, (length- 60m x Inner Diameter-0.53 mm), Film Thickness-3.0 μm; using Nitrogen as Carrier Gas, Hydrogen as Flammable gas and Zero air as Oxidizing agent with Flow rate 3.5 mL/min, Detector temperature-250oC, Injection mode-Split and Ratio-1:1, Linear velocity-24.4 cm/sec, Flow control mode- Pressure, Total flow- 10.0 mL/min, Run time-30 minutes. All Solvents are separated well with the acceptance Criteria limit of Resolution.