HPLC-ELSD测定肠外营养用海豹油脂肪乳中溶血磷脂酰胆碱的含量  被引量:7

Content Determination of Lysophosphatidylcholine in Seal Oil Based Lipid Emulsion for Parenteral Nutrition by HPLC-ELSD

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作  者:江桂生[1,2] 苏健芬[1] 付寒[1,2] 邢静娴[1] 董怡萱[1] 吴传斌[1,2] 

机构地区:[1]中山大学药学院,广州510006 [2]广东省创新药物制剂工程技术研究中心,广州510006

出  处:《中国现代应用药学》2012年第5期440-444,共5页Chinese Journal of Modern Applied Pharmacy

基  金:科技部国际科技合作与交流专项项目(2008DFA31080)

摘  要:目的建立HPLC-ELSD测定肠外营养用海豹油脂肪乳中溶血磷脂酰胆碱的含量。方法采用硅胶色谱柱(MZ-ANALYTICAL Spherisorb,250 mm×4.6 mm,5μm),流动相A为甲醇-水-冰醋酸-三乙胺(850∶1 50∶4.5∶0.5),流动相B为甲醇-水-冰醋酸-三乙胺-正己烷-异丙醇(385∶68∶2∶0.23∶1 60∶3 84),等度洗脱,A∶B=30∶70,流速为1.0mL.min1;进样体积为20μL,柱温为40℃;蒸发光散射检测器,漂移管温度为70℃,雾化气为氮气,气体流量为2 L.min1。结果线性范围为0.02~0.4 mg.mL1(r=0.999 4),检测限为0.12μg(S/N=3),定量限为0.40μg(S/N=10,n=3),平均回收率为100.3%,RSD为0.54%(n=9)。结论该方法灵敏、快速、准确、重复性好、专属性强,可用于本制剂的质量控制。OBJECTIVE To establish an HPLC method for determining the content of lysophosphatidylcholine in seal oil based lipid emulsion for parenteral nutrition.METHODS Using a silicone column(MZ-ANALYTICAL Spherisorb,250 mm×4.6 mm,5 μm) as the stationary phase,the mobile phase A was: methanol-water-glacial acetic acid-triethylamine(850∶150∶4.5∶0.5),and the mobile phase B was: methanol-water-glacial acetic acid-triethylamine-n-hexane-isopropanol(385∶68∶2∶0.23∶160∶384),and the ratio of A and B was 30∶70 with isocratic elution.The flow rate was 1.0 mL·min 1.The injection volume was 20 μL.The column temperature was set at 40 ℃.The detector was evaporative light-scattering detector(ELSD).The drift tube temperature of the ELSD was set at 70 ℃,and the nitrogen flow rate of the ELSD was 2 L·min 1.RESULTS The linear concentration range of lysophosphatidylcholine was 0.02 0.4 mg·mL 1(r=0.999 4),and the average recovery was 100.3% with the RSD of 0.54%(n=9).The limit of detection was 0.12 μg(S/N=3),and the limit of quantitation was 0.40 μg(S/N=10,n=3).CONCLUSION This method is rapid,accurate,reliable and reproducible.It is suitable for the quality control of seal oil based lipid emulsion for parenteral nutrition.

关 键 词:高效液相色谱法 蒸发光散射检测器 海豹油 脂肪乳 溶血磷脂酰胆碱 含量测定 

分 类 号:R917.101[医药卫生—药物分析学]

 

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