Validation Of Novel Hplc Method For Quantitative Determination Of Cefotaxime Sodium In Nanostructure Lipid Carriers

Abstract

Cefotaxime (CFT) 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. CFT was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of Agilent (Zorbax) C₁₈ column (250 mm × 4.6 mm i.d., 5.0μm) and a mobile phase composed of phosphate buffer (pH7.4): methanol (70:30v/v) at a flow rate of 1.2 ml/min. The samples were measured at 234nm using UV detector. The column temperature was kept at 25°C; the run time was 7 min; the injection volume was 20µl. CFT was separated within 6.245±0.04min. The correlation coefficient for the obtained calibration curve was found to be 0.999. The method was validated according to ICH Q2 (R1) guidelines for linearity, sensitivity, robustness, accuracy and precision. The LOD and LOQ were found to be 0.100 and 0.314μg/ml, respectively. The developed and validated method was successfully applied for the quantitative analysis of nanostructure lipid carriers (NLCs). The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of CFT in respective dosage form.