Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms

Abstract

A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R2=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.