本文關(guān)鍵詞： 四環(huán)素 純度標(biāo)準(zhǔn)物質(zhì) 雜質(zhì)鑒定 差向四環(huán)素 金霉素 脫水四環(huán)素 差向脫水四環(huán)素 高效液相色譜-質(zhì)譜 穩(wěn)定性 不確定度　出處：《藥物分析雜志》2015年11期 　論文類型：期刊論文

【摘要】：目的:研制獸藥四環(huán)素的純度標(biāo)準(zhǔn)物質(zhì)并對其雜質(zhì)進(jìn)行鑒定;方法:采用超高效液相色譜-高分辨飛行時間質(zhì)譜(UPLC-HRTOF/MS)對四環(huán)素及其雜質(zhì)進(jìn)行定性分析,采用高效液相色譜法對四環(huán)素標(biāo)準(zhǔn)物質(zhì)進(jìn)行定值以及均勻性和穩(wěn)定性檢驗(yàn),并對標(biāo)準(zhǔn)值的不確定度進(jìn)行評估。結(jié)果:UPLC-HRTOF/MS鑒定出四環(huán)素中的4種雜質(zhì),分別為差向四環(huán)素、金霉素、差向脫水四環(huán)素和脫水四環(huán)素。四環(huán)素純度標(biāo)準(zhǔn)物質(zhì)定值結(jié)果為95.6%,擴(kuò)展不確定度為1.1%(k=2)。在-20℃下避光保存可以保證在12個月內(nèi)量值穩(wěn)定。結(jié)論:四環(huán)素標(biāo)準(zhǔn)物質(zhì)符合國家標(biāo)準(zhǔn)物質(zhì)的技術(shù)要求,可為食品檢驗(yàn)、衛(wèi)生檢驗(yàn)檢疫、科學(xué)研究等方面的測量和研究工作提供技術(shù)支撐和量值溯源保障。
[Abstract]:Objective: to prepare the purity standard substance of veterinary drug tetracycline and to identify its impurity. Methods: the tetracycline and its impurity were qualitatively analyzed by UPLC-HRTOF / MS by ultra-high performance liquid chromatography-high resolution time-of-flight mass spectrometry. The determination, uniformity and stability of tetracycline reference materials were determined by high performance liquid chromatography (HPLC). The uncertainty of the standard value was evaluated. Results the four impurities in tetracycline were identified as differential tetracycline and chlortetracycline. Differential dehydration tetracycline and dehydrated tetracycline. The purity of tetracycline is determined to be 95.6%. The extended uncertainty is 1.1 / kg ~ 2 ~ (2). The quantity of tetracycline can be kept stable within 12 months by keeping away from light at -20 鈩，

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