Journal of Pharmaceutical and Biomedical Analysis 2003-11-24

A simple and sensitive GC method for determination of N-methylpyrrolidine in cefepime and its preparation.

Guiliang Chen, Guyu Liu, Feng Qin, Yiting Wang

Index: J. Pharm. Biomed. Anal. 33(4) , 797-801, (2003)

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Abstract

A new, simple and rapid gas chromatographic method was developed for the determination of N-methylpyrrolidine (NMP) in cefepime and its preparation. NMP was extracted with chloroform from cefepime and its preparation. An HP-1 column was maintained at 100 degrees C. Both the injector and the FI detector were set 250 degrees C. Pyridine was used as an internal standard. The detector response was linear up to 135 ng. The detection limit was 0.3 ng. The recoveries were 100.2-103.0% at three concentration levels. No interference from organic solvents presented in the synthesis was observed. The proposed method has a potential for application in quality control for cefepime and its preparation.