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高效液相色谱法测定丙泊酚中/长链脂肪乳注射液中甘油的含量

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目的 建立用高效液相色谱法测定丙泊酚中/长链脂肪乳注射液中甘油含量的方法.方法 采用高效液相色谱法,色谱柱为Kromasil 100-5-NH2柱(4.6×250mm,5μm),流动相为乙腈-水(8515),流速为1.0mL/min,柱温为40℃,示差折光检测器,检测器温度为40℃.结果 甘油浓度在455.3916~2276.9580μg/mL范围内,其浓度与峰面积呈良好线性关系(r=0.9999,n=7);平均回收率为99.5%,RSD=0.6%(n=9);检出限为121ng,定量限为364ng.结论 所建立的方法简单、快速、准确、专属性强,重现性好,可用于丙泊酚中/长链脂肪乳注射液中甘油含量的测定.
Determination of glycerol in propofol medium and long chain fat emulsion injection by HPLC
Objective A high performance liquid chromatographic (HPLC) method was established for the determination of glycerol in propofol medium and long chain fat emulsion injection.MethodsThe chromatographic conditions were as follows: Kromasil 100-5-NH2 column(4.6×250mm,5μm) with the column temperature was 40℃,acetonitrile-water(8515)as mobile phase with flow rate of 1.0mL/min.Glycerol was detected by refractive index (RI) detector at 40℃.ResultsThe linear range of glycerol was 455.3916-2276.9580μg/mL(r=0.9999,n=7),the average recovery rate was 99.5%,RSD was 0.6%(n=9),the limit of detection(LOD) was 121ng and the limit of quantification(LOQ)was 364ng.ConclusionThe method was simple, rapid, strong specifity and accurate with good reproducibility, which is suitable for the content determination of glycerol in propofol medium and long chain fat emulsion injection.

high performance liquid chromatographic (HPLC)propofol medium and long chain fat emulsion injectionglycerolcontent determination

周朝东、苏喆、马冰、白海娇、黄哲甦

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天津市药品检验研究院,天津300070

高效液相色谱法 丙泊酚中/长链脂肪乳注射液 甘油 含量测定

2017

中国生化药物杂志
南京生物化学制药研究所,全国生化制药情报中心站,中国生化制药工业协会,中国药品生物制品检定所

中国生化药物杂志

ISSN:1005-1678
年,卷(期):2017.(5)
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