HPLCCDD Determination of cefepime hydrochloride and its preparations in the Nmethyl-pyrrolidine content.docVIP

 PAGE \* MERGEFORMAT 10 HPLCCDD Determination of cefepime hydrochloride and its preparations in the Nmethyl-pyrrolidine content Author: TAN Sheng-Min Cui-Lian Lu Yuan Xu passers-by [Abstract] Objective To establish a high-performance liquid  conductivity method (HPLC  CDD Act) Determination of cefepime hydrochloride in N  methyl-pyrrolidine-content. Methods carboxylic acid bonded silica column for the analysis of the filler metrosep C2 (100mm * 4.0mm, 7μ m); mobile phase was 0.01mol / L nitric acid solution: acetonitrile (99:1); flow rate 1ml/min; column temperature was 35 ℃ ; sample volume 20μ l; detector: conductivity detector. The results of N  methyl-pyrrolidine in the concentration range of 4.8 ~ 38.8μ g/ml and the peak area showed good linear relationship, r = 0.9999. High, medium and low concentrations of three kinds of average recovery of 101.2%, RSD of 1.3%. Conclusion The method is simple, accurate, high sensitivity, good reproducibility and can be used as cefepime hydrochloride in N  methyl-pyrrolidine method for the determination. [Keywords:] HPLC  CDD; N  methyl-pyrrolidine; Cefepime Hydrochloride for Injection ABSTRACT Objective To develop an HPLC method for the determination N  methylpyrrolidine in cefepime dihydrochloride. Method The chromatographic condition: the column was a silica gel with caboxyl groups particle (metrosep C2 100mm * 4.0mm, 7μ m). The mobile phase consisted of acetonitrile: 0.01 mol / L nitric acid (1:99), an electric conductivity detector was used, the flow rate was 1.0ml/min, the column temperature was 35 ℃ . Results The calibration curve was linear (r = 0.9999) in the range of 4.8 ~ 38.8 μ g / ml for N  methylpyrrolidine, the average recovery was 101.2% (n = 9), and the average RSD was 1.3%. Conculsion The method is accurate, simple, rapid, and with good reproducibility for quality content of N  methylpyrrolidine in cefepime hydrochloride. KEY WORDS HPLC  CDD; N  methylpyrrolidine; Cefepime hyd