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 the Cephalosporin antibiotics. It used on a wide scale in prescribed antibiotic drugs as anti-infection for gram-positive microorganisms and gram-negative microorganisms. The present study aimed to develop an HPLC method of Cfm analysis enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly and economical to use. The chromatographic method uses a reversed phase column BDS column (150 mm x 4.0 mm x 5 μm). The mobile phase was prepared by mixing Methanol: Phosphate buffer (1000 mL : 130 mL) and the pH was adjusted to 6.15 at isocratic flow rate 1.0 mL/min with PDA detector at 235nm, column oven adjusted at 30°C and injection volume 20 μL. The method revealed that satisfied linearity regression R² (0.9992) with repeatability (0.15%) with DL and QL; 35.5 ng/mL and 107.6 ng/mL respectively. The method showed a successful application of analytical method validation for Cfm in bulk and pharmaceutical formulations.