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机构地区:[1]新疆维吾尔自治区药物研究所,乌鲁木齐830004 [2]新疆科丽生物技术有限公司,乌鲁木齐830011
出 处:《中国药房》2012年第45期4285-4286,共2页China Pharmacy
基 金:新疆维吾尔自治区高技术研究发展计划资助项目(201110103)
摘 要:目的:测定氯高铁血红素原料药中的冰醋酸残留量。方法:采用毛细管气相色谱法。色谱柱为PEG-20M的石英毛细管柱,柱温为160℃,氢火焰离子化检测器,温度为250℃,载气为氮气,助燃气为氢气和空气,以蒸馏水为溶剂制备溶液直接进样,进样量为1.0μL。结果:冰醋酸检测浓度线性范围为0.00638~0.12751mg·mL-1(r=1.0000);低、中、高浓度平均回收率(n=9)分别为98.98%、97.76%、98.86%,RSD分别为3.19%、2.06%、1.98%;最低检测限为0.00076mg·mL-1。结论:该法可用于氯高铁血红素原料药中冰醋酸残留量的检测。OBJECTIVE:To establish the method for the determination of residual glacial acetic acid in hematin chloride raw materials.METHODS:Capillary gas chromatography was adopted.The determination was performed on PEG-20M quartz capillary column with column temperature of 160 ℃.Flame ionization detector was used and the temperature of it was 250 ℃ with nitrogen as carrier gas,and hydrogen and air as auxiliary gas using distilled water as solvent for direct-injection detection.The injection volume was 1.0 μL.RESULTS:The linear range of glacial acetic acid was 0.006 38~0.127 51 mg·mL-1(r=1.000 0);the average recoveries were 98.98%,97.76% and 98.86% at low,middle and high concentration(n=9) with RSD of 3.19%,2.06% and 1.98%.The detection limit was 0.000 76 mg·mL-1.CONCLUSION:The method can be used to detect residual glacial acetic acid in hematin chloride raw materials.
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