Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF PHENYTOIN BULK AND PHARMAEUTICAL DOSAGE FORM.

Sagar S. Yenare*, J. B. Wadekar, M. S. Tare and C. G. Dhaygude

ABSTRACT

Current study is conducted to progress easy UV spectrophotometric technique to Estimation Phenytoin in Pharmacuetical dosage form. The Absorbance solution was prepare by weighing 100 mg of Phenytoin in 100ml methanol in Volumetric flask. All dilution were prepared as per procedure and this will scanned at 247 nm. The Linearityt found in concentration range of 1-5 μg/ml the correlatioin coeifficient was 0.997. The line Regession Equation was found to be Y=0.315X-0.038.The validated method for linearty, accuracy, precision, LOD, LOQ, and Robustness ruggedness. The LOD and LOQ for estimation of phenytoin was found to be 0.015 (μg/ml) and 0.030μg/ml,the percentage recoveryof phenytoin was found tobe in range of 100.25±0.070-100.60±0.045. The developmed Method is also useful for quality control of both bulk production as well as Pharma Dosage Froms.

Keywords: Phenytoin, UVspectroscopy, Method Validation ICH Guidelines.