气相色谱法测定静注人免疫球蛋白（pH4）辛酸含量 - 中国药品标准杂志.DOCVIP

气相色谱法测定人血白蛋白中辛酸钠含量 赵明芬1，王霞1，李荣贞1,2，张华1，张晓杰1* . 山东泰邦生物制品有限公司，泰安 271000；2.山东省生物制品研究所，泰安 271000 摘要 目的 ：建立气相色谱法测定人血白蛋白中辛酸钠的含量。方法 色谱条件：色谱柱KBINNOWAX（30m×0.32mm×0.5μm）；气化室温度250℃；柱温190℃；检测器温度250℃；载气为氮气，柱流速3.0min-1； 氢气流速40min-1；分流比10:1，乙酸乙酯为萃取剂（溶剂）。专属性、重复性、线性、溶液稳定性、准确度、定量限。结果气相色谱法，重复性RSD为0.74%线性范围在157～785μg溶液在24h内稳定，峰面积RSD为1.01%平均回收率及RSD分别为96.72%±0.93%、0.96%，定量限为5.23μg。结论气相色谱法人血白蛋白中辛酸钠的含量操作简便、准确。 关键词：人血白蛋白；气相色谱法；辛酸钠含量 中图分类号：R 91.2 文献标识码：A 文章编号：1009-3656（2017） Determination of Sodium Caprilate in the Human Albumin Semi-finished Product by Gas Chromatography Zhao Mingfen1, WangXia1，L Rongzhen1,2, ZhangHua1,Zhang Xiaojie1* （1. Shandong Taibang Biological Products Co., Ltd, Taian 271000； 2 Shandong Institute of Biological Products, Taian 271000） Abstract Objective: To establish a method for determination of Sodium Caprilate in the Human Albumin semi-finished product by gas chromatography. Methods: The chromatographic conditions were as follows: KB INNOWAX column(30m×0.32mm×0.5μm)； the gasification room temperature as 250℃; the column temperature as 190℃; the detector temperature was 250℃, N2 as the carrier gas and column flow rate as 3.0 mL·min-1;hydrogen flow rate was 40mL·min-1; the split ratio as 10:1; and ethyl acetate as the extraction solvent. The specificity, repeatability, linearity range, solution stability, accuracy and limit of quantification of this method were validated. Results： The tailing factor of Caprilate peak was 1.10, its theoretical plate number was 21251, and the resolution of Caprilate peak with adjacent peaks was 5.1. The RSD of repeatability was 0.74%, the linearity range was 157-785μg·mL-1, and the RSD of peak area for the solution stability within 24 hours was 1.01%. The average recovery was 96.72% ± 0.93% with RSD as0.96%. The LOQ was 5.23μg. Conclusion： The method is simple, and reliablewhich can be used for determination of Sodium Caprilate in the Human Albumin semi-finished product. Key words：Human Albumin; Gas Chromatography; Sodium Capri