Development and Validation of a Green Analytical Method of RP-HPLC for Quantification of Cefepime Hydrochloride in Pharmaceutical Dosage Form: Simple, Sensitive and Economic

Abstract

Introduction: A green analytical method simple, rapid and economic was validated for the determination of cefepime hydrochloride and has been developed using reversed phase high performance liquid chromatography (RP-HPLC) in pharmaceutical preparations. Methods: The liquid chromatography method was carried out using as mobile phase a mixture of ethanol and water (55: 45, v/v), on column Luna C18 (250 x 4.6 mm; 5 mu m) at a flow rate of 0.5 mL min-1 with UV detection at 258 nm. Results: The method was validated according to ICH guidelines, presenting optimum linearity in the range 10-70 mu g mL(-1) (r = 1.0000) and retention time (tR) equal to 4.99 minutes. Statistical analyses were performed for the validated method, proving the safety and reliability of the results. Other important factors is that the method uses less amounts of organic solvent, produces low levels of waste and does not use buffer solution, minimizing effluent treatment, which contributes to the environment and implements methods aimed green chemistry, making economic for the industry. Conclusion: Thus, the method can be employed as an alternative in quality control routine analysis of pharmaceutical industry for quantification of cefepime hydrochloride lyophilized powder for solution for injection.