Validation of Analytical Method of Testing Cefotaxime Sodium in Injection Powder Preparation by High-Performance Liquid Chromatography

Abstract

Cefotaxime sodium is an antibiotic drug that is included in the third-generation cephalosporin group. The aims of this research is to validate the method used for the analysis of cefotaxime sodium injection powder using HPLC. Parameters performed in this study include system suitability, selectivity, linearity, accuracy, precision, robustness, Limit of Detection (LOD), and Limit of Quantitation (LOQ). In this study, the mobile phase used was phosphate buffer pH 6,25 with methanol in the ratio of (30:70), (40:60), (50:50), (60:40) and (70:30) v/v. The analysis was carried out using a 150 × 4,6 mm 5µm C18 column and phosphate buffer pH 6,25 with methanol (40:60) v/v as a mobile phase with a flow rate of 1 mL/min, detector at wavelength 235 nm. The results showed that the system suitability test results met the requirements, plate number of 2288, standard deviation 0,93% and tailing factor 1,3. The linearity results met the requirements of r ≥ 0,999 with LOD and LOQ value of 3,3894 ×10-4 mg/mL 1,0271 ×10-3 mg/mL respectively. The accuracy results obtained a recovery value 99,30%, RSD 0,48%, precision results of repeatability and intermediate with RSD 0,38% and 0,85%, respectively, robustness test results obtained a recovery value of 100,25% and RSD 0,85%. The results showed that the recovery values (98-102%) and RSD ≤ 1,5% were in accordance with the validation requirements. It can be concluded that the validation of the proposed method is recommended and can be used for routine analysis