Abstract

EXTRACTIVE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF CEFEPIME HYDROCHLORIDE IN TABLET FORMULATION

Chimatapu H.S. Venkataramana, Suma. B. Venkatappa* and Joel M. Thachemperil

ABSTRACT

A Simple, accurate and convenient sensitive extractive spectrophotometric method based on the ion-association reaction between cefepime hydrochloride and a bromophenol blue, in phosphate buffer pH 3.0 was developed. The developed method involve formation of reddish orange chromogen extractable in chloroform layer. The method was validated according to international conference on harmonization (ICH) guideline, the extracted complex showed the λmax at 417 nm, with good linearity in the range of 2 – 24 μg/mL with R2 value of 0.9976.The % RSD was found to be < 2%. The accuracy, precision and sensitivity of extractive spectrophotometric method shows that the developed method is better for estimation of Cefepime Hydrochloride in tablet.

Keywords: Cefepime hydrochloride, bromophenol blue, extractive spectrophotometric method, Validation, International conference on harmonization guidelines.