HPLC Analytical Method Validation for Determination of Cefotaxime in the Bulk and Finished Pharmaceutical Dosage Form

Abstract

Cefotaxime (Cfm) is a member of the third generation of cephalosporin antibiotics. It is used on a wide scale in prescribed antibiotic drugs as an anti-infection treatment for gram-positive and gram-negative microorganisms. The present study aims to develop an HPLC method for Cfm analysis that demonstrates high linearity, repeatability, robustness, ruggedness, selectivity, rapidity, and cost-effectiveness. The chromatographic method employs a reversed-phase BDS column (150 mm × 4.0 mm × 5 μm). The mobile phase was prepared by mixing methanol and phosphate buffer (1,000 mL : 130 mL), and the pH was adjusted to 6.15 at an isocratic flow rate of 1.0 mL/min with a PDA detector set at 235 nm, a column oven adjusted to 30 °C, and an injection volume of 20 μL. The method revealed satisfactory linearity with a regression R² of 0.9992 and repeatability of 0.15%, with detection limit (DL) and quantitation limit (QL) of 35.5 ng/mL and 107.6 ng/mL, respectively. The method demonstrated the successful application of analytical method validation for Cfm in bulk and pharmaceutical formulations.