Open AccessDEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR PHENYTOIN SODIUM AND PHENOBARBITONE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Author(s) -
Radhika Shah,
Ragin Shah
Publication year - 2017
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2017v9i10.19917
Subject(s) - chromatography , phenytoin , high performance liquid chromatography , chemistry , dosage form , sodium , phosphate buffered saline , medicine , epilepsy , organic chemistry , psychiatry
Objective: To develop an accurate, simple, rapid, precise, and linear RP-HPLC method for the simultaneous estimation of phenytoin sodium and phenobarbitone in tablet dosage form and validated as per ICH guidelines.Methods: The method used was a reverse phase HPLC (RP-HPLC) method using Hypersil BDS C18, (250×4.6 mm, 5 μm) column, mobile phase comprising of methanol: phosphate buffer (pH 5.0) (50:50), flow rate of 1.0 ml/min and a detection wavelength of 215 nm using a UV detector.Results: The retention time for phenytoin sodium and phenobarbitone was found to be 3.97 min and 6.90 min, respectively. The linearity of developed method was achieved in the range of 10-30 μg/ml for phenytoin sodium and 3-9 μg/ml for phenobarbitone. The detection (LOD) and quantitation (LOQ) limits were 1.44 and 4.36 µg/ml for phenytoin sodium and 0.40 and 1.35 µg/ml for phenobarbitone respectively.Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of phenytoin sodium and phenobarbitone in bulk and pharmaceutical formulation. The method was validated as per ICH guidelines. Hence, the method holds good for the routine analysis of phenytoin sodium and phenobarbitone in various pharmaceutical industries as well as in academics.