Volume :
1
Issue :
3
Abstract :
A simple, stability-indicating, reversed-phase liquid chromatographic method was developed for the determination of Cefotaxime sodium in the presence of its degradation products. The analysis was carried out by using ODS (150 x 4.6mm) 5µm column. Mobile phase used was a mixture of buffer, methanol and acetonitrile in the ratio of 80:15:05, at a flow rate of 1.3 mL per minute and injection volume of 20µL with UV-detection at 254 nm with a run time of 10 minutes. The stability indicating capability of the method was proven by subjecting the drugs to stress conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation and resolution of the degradation products formed therein. This method showed good linearity in the range of 51.348 to 359.438 μg/mL. The suggested method was successfully applied for the analysis of Cefotaxime sodium from injection formulation and found the average assay data of 98.86% with a relative standard deviation of 0.48% for 6 samples. The Cefotaxime sodium was found to be stable in solution up to 14 hours at room temperature. The method validation data showed excellent results for precision, linearity and specificity. The present method can be successfully used for routine quality control and stability studies.