Abstract

A new validated liquid chromatographic method for the determination of impurities in fosphenytoin sodium

Author(s): Sigala Ashok, M.Satish Varma, CH.V.Raghunadha Babu, G.Balaswamy

An improved gradient, reversed-phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of Fosphenytoin sodium and its process-related impurities. Separation achievedwith Symmetry shield RP-18, 2504.6mm, 5 column and amobile phase of buffer (0.05Mmonobasic potassiumphosphate and 30mL of 0.5M dodecyltriethylammonium phosphate in 900ml of water, adjust with 1.5M phosphoric acid to a pH of about 3.0.)Acetonitrile with gradient elution at a flow rate of 1.0mL min-1. UV detection was performed at 214nm. The described method is linear over a range of LOQ to 6.75g mL-1 (150% of the specification limit) for all the process-related impurities. The accuracy of the method demonstrated and the recovery of impurities were found to be in the range of 85-110%. Themethod is simple, rapid, selective, accurate for the quantification of process related impurities of Fosphenytoin in its bulk drug samples.