Green RP-HPLC Method Development and Validation for Simultaneous Determination of Cefepime Hydrochloride and Avibactam Sodium in Bulk Drug and Laboratory-Prepared Mixture

Abstract

A simple, rapid, accurate, precise and environmentally friendly RP-HPLC Method Development and Validation. Chromatographic separation was accomplished on a C18 octadecylsilane column with methanol: phosphate buffer as the mobile phase at 0.9 mL/min and detection at 220 nm. The retention times for Avibactam Sodium and Cefepime Hydrochloride were 3.95 min and 9.22 min, respectively. We validated the developed method in compliance with ICH Q2 (R2) guidelines, the maximum concentration for avibactam sodium and cefepime hydrochloride showed excellent linear regressions by plotting calibration curves; correlation coefficient was 0.9990, 0.9991and range of concentrations were from5 to 25 μg/mL respectively. The accuracy studies observed the mean recoveries from Avibactam Sodium in a range of 98.20–99.91%. and 99.23–100.73% for Cefepime Hydrochloride. For precision studies, the %RSD values were found to be < 2%, indicating good reproducibility. The LOD and LOQ were determined to be 0.05 and 0.15 µg/mL for Avibactam Sodium, and 0.039 and 0.1197 µg/mL for Cefepime Hydrochloride respectively (results are displayed in Table3) Table3. The method showed appropriate robustness also during designed changes in chromatographic conditions. Greenness was determined with an Analytical Eco-scale score of 85 and MoGAPI score of 74. The proposed method can be effectively utilized for the routine quantitative assay of Cefepime Hydrochloride and Avibactam Sodium.