Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CEFIXIME IN BULK AND TABLET DOSAGE FORM

Zeba Mahamad Hanif Gaibu*, Dr. Mallinath Shankarappa Kalshetti, Kaveri Chandrakant Dulange, Shubhangi Sidram Bamgonde, Neha Ranjeet Gate

ABSTRACT

A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Cefixime trihydrate in bulk and its tablet dosage form. The drug shows maximum absorption (λmax) at 288 nm in methanol and obeys Beer’s law in the concentration range of 2-10 μg/ml with correlation coefficient ( R2=0.999). The accuracy was found to be 98-99%. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.042 μg/ml and 0.096 μg/ml respectively. The relative standard deviation was found to be <2.0%in all cases. The proposed spectrophotometric method was validated as per ICH Q2 (R1) guidelines. Statistical analysis proved that the method is repeatable and specific for the determination of the said drug. The proposed method can be used for the reliable quantification of cefixime trihydrate in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Cefixime trihydrate, UV Spectrophotometer, Method Validation.