Abstract

METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR ESTIMATION OF PHENYTOIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sagar S. Yenare* and Gaurav S. Lodha

Abstract

In the Current scenario there is a need for a creation of a useful RPHPLC methods for various types of drug. Thus a easy, reproducible and trustworthy reversed phase high performance liquid chromatographic (RP-HPLC) method is developed and validated for the estimation of Phenytoin. Jasco System was utilized to carry out chromatography with an UV 730 D detector. On C18 (4.6x250 mm) column. The mobile phase used is Mehanol: Distill water (50:50 V/v) at a floe rate of 1 ml / min. The pH of mobile phase 3. Detection was done with a UV detector at 254 nm. As per the ICH guidelines, parameters such as precision, linearity, accuracy, ruggedness, LOD and LOQ were studied. The retention of Pheneytoin was 5.174. the Linearity range was found to be. The correlation coefficients of phenytoin obtained were 0.979. The developed method was found to be reliable, accurate and easy for simultaneous estimation of Phenytoin in pharmaceutical dosage forms. The developed method is also useful for quality control of both bulk manufacturing as well as pharmaceutical dosage forms.

Keywords: Phenytoin, method validation, RP-HPLC, ICH guidelines.