Determination of cefixime in 100 mg hard capsules by UV-Vis and HPLC methods according to USP and ICH guidelines

Abstract

Cefixime is a broad-spectrum antibiotic belonging to the third-generation cephalosporin class, widely used for the treatment of bacterial infections. Quality control of pharmaceutical formulations containing cefixime is essential to ensure product safety and therapeutic efficacy. However, limited analytical instrumentation in many local quality control laboratories necessitates the selection of analytical methods appropriate to practical conditions. This study aimed to compare two analytical methods for the quantification of cefixime in 100 mg hard capsules, including high-performance liquid chromatography (HPLC) and UV-Visible spectrophotometry (UV-Vis), using the Fisher statistical test. The HPLC method employed a reversed-phase C18 column with a mobile phase consisting of acetonitrile and tetrabutylammonium hydroxide solution in a 1:3 (v/v) ratio, and detection at a wavelength of 288 nm. The UV-Vis method was developed over a linear concentration range of (0.00597-0.01593) mg∙mL⁻¹, with recovery values ranging from 99.77 % to 101.00 %. Validation results demonstrated that both methods satisfied the requirements for accuracy, precision, and linearity in accordance with ICH guidelines. The novelty of this study lies in the application of statistical testing to evaluate the equivalence between the two analytical methods. The findings provide practical implications for selecting appropriate analytical approaches under limited laboratory conditions, contributing to the improvement of quality control practices in local pharmaceutical testing laboratories.