【摘要】：目的:采用色譜-質(zhì)譜聯(lián)用技術(shù)鑒定頭孢妥侖匹酯的有關(guān)物質(zhì),為其工藝優(yōu)化和質(zhì)量控制提供參考依據(jù)。方法:采用YMC-Pack ODS-AM(150 mm×4.6 mm,5μm)色譜柱,以甲醇-乙腈-乙酸銨緩沖液為流動相,梯度洗脫,對頭孢妥侖匹酯有關(guān)物質(zhì)進(jìn)行分離;采用電噴霧正離子化-飛行時間質(zhì)譜法(ESI-TOF/MS)測定各有關(guān)物質(zhì)離子的準(zhǔn)確質(zhì)量和元素組成,三重四極質(zhì)譜(ESI-MS/MS)測定子離子特征。結(jié)果:在所建立的條件下,頭孢妥侖匹酯及其有關(guān)物質(zhì)分離良好,檢測并鑒定出10個主要有關(guān)物質(zhì)。結(jié)論:色譜-質(zhì)譜聯(lián)用技術(shù)能有效地分離鑒定頭孢妥侖匹酯中的有關(guān)物質(zhì),鑒定結(jié)果為其質(zhì)量控制和工藝優(yōu)化提供了參考。
[Abstract]:Objective: to identify the related substances of ceftol by chromatography-mass spectrometry (GC-MS), and to provide reference for its process optimization and quality control. Methods: YMC-Pack ODS-AM (150 mm 脳 4.6 mm, 5 渭 m) column was used, methanol-acetonitrile-ammonium acetate buffer was used as mobile phase, gradient eluting, electrospray positive ionization-time-of-flight mass spectrometry (ESI-TOF/MS) was used to determine the accurate mass and element composition of the ions, and triple quadrupole mass spectrometry (ESI-MS/MS) was used to determine the characteristics of the subions. Results: under the established conditions, ceftol and its related substances were separated well, and 10 main related substances were detected and identified. Conclusion: chromatography-mass spectrometry (GC-MS) can effectively isolate and identify the related substances in ceftopiramate, and the identification results provide a reference for quality control and process optimization.
【作者單位】： 中國藥科大學(xué)藥物分析教研室;江蘇省食品藥品監(jiān)督檢驗研究院;江蘇省信諾醫(yī)藥對外貿(mào)易有限公司;
【分類號】：R927

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