Trace Level Determination of p-Toluidine in Penem Drug Substances by Gas Chromatography

[摘要] A Gas chromatographic method using flame ionization detector (GC-FID) has been developed and validated for the quantitative determination of p-Toluidine in Meropenem trihydrate, Imipenem monohydrate, Doripenem monohydrate and Ertapenem monosodium pharmaceutical drug substances. The chromatographic method was achieved on fused silica capillary column (Rtx-5) with 5% diphenyl and 95% dimethyl polysiloxane stationary phase. The detection and quantitation limits obtained for p-Toluidine were 0.9 µg g-1 and 2.7 µg g-1 respectively. The relative standard deviation for analyte response was found as 0.9% for six replicate injections of standard equivalent to 100 µg g-1 of p-Toluidine. The average recoveries of p-Toluidine in Meropenem trihydrate, Imipenem monohydrate, Doripenem monohydrate and Ertapenem monosodium were obtained 99.6%, 99.2%, 96.7% and 107.9% respectively. The method was found to be linear in the range between 2.7 and 150 µg/g with a correlation coefficient 0.9999. The developed method was found to be robust for the determination of p-Toluidine in Penem drug substances.

[学科分类] 分析化学

[关键词] : p-toluidine by GC;meropenem trihydrate;imipenem monohydrate;doripenem monohydrate;ertapenem monosodium