| 引用本文: | 江桂生，苏健芬，付寒，邢静娴，董怡萱，吴传斌.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[J].中国现代应用药学,2012,29(5):440-444. |
| JIANG Guisheng, SU Jianfen, FU Han, XING Jingxian, DONG Yixuan, WU Chuanbin.Content Determination of Lysophosphatidylcholine in Seal Oil Based Lipid Emulsion for Parenteral Nutrition by HPLC-ELSD[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(5):440-444. |
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| 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，5 μm)，流动相A为甲醇-水-冰醋酸-三乙胺(850∶150∶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∶160∶384)，等度洗脱，A∶B = 30∶70，流速为1.0 mL·min-1；进样体积为20 μL，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·min-1。结果 线性范围为0.02~0.4 mg·mL-1(r=0.999 4)，检测限为0.12 μg(S/N=3)，定量限为0.40 μg(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。 |
| 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 |
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| 基金项目:科技部国际科技合作与交流专项项目(2008DFA31080) |
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| Content Determination of Lysophosphatidylcholine in Seal Oil Based Lipid Emulsion for Parenteral Nutrition by HPLC-ELSD |
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JIANG Guisheng, SU Jianfen, FU Han, XING Jingxian, DONG Yixuan, WU Chuanbin1,2
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1.School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou 510006, China;2.Guangdong Research Center for Drug Delivery Systems, Guangzhou 510006, China
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| Abstract: |
| 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. |
| Key words: HPLC ELSD seal oil lipid emulsion lysophosphatidylcholine content determination |
