| 引用本文: | 杨俊,谢俊.HPLC-ELSD测定多西他赛注射用浓溶液中溶血磷脂酰乙醇胺、溶血磷脂酰胆碱的含量[J].中国现代应用药学,2013,30(11):1210-1215. |
| YANG Jun,XIE Jun .Determination of Lyso-phosphatidylethanolamine and Lyso-phosphatidylcholine in Docetaxel Concentrated Solution for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(11):1210-1215. |
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| 摘要: |
| 目的 建立同时测定多西他赛注射用浓溶液中的溶血磷脂酰乙醇胺(LPE)、溶血磷脂酰胆碱(LPC)含量的HPLC-ELSD。方法 采用YMC Pack PVA-Sil(150 mm×2 mm，5 μm)色谱柱，以三氯甲烷为流动相A、甲醇-水(93.5∶6.5)为流动相B，梯度洗脱，流速为0.4 mL·min-1，柱温为25 ℃，蒸发光散射检测器检测，检测器漂移管温度：100 ℃，雾化气：空气，气体流量为2.0 L·min-1。结果 LPE和LPC峰面积的对数与相应的浓度的对数呈良好的线性关系，线性范围分别为0.203~0.811 μg(r=0. 999 0)和0.407~6.102 μg(r=0.999 6)，LPE 3个浓度的平均加样回收率分别为104.1%，95.1%，101.6%，RSD分别为3.8%，0.3%，2.4%，LPC 3个浓度的平均回收率分别为108.7%，104.5%，105.5%，RSD分别为1.0%，3.0%，2.6%。结论 该法简单、准确、重复性好，可用于多西他赛注射用浓溶液中大豆磷脂分解产物的质量控制。 |
| 关键词: 多西他赛注射用浓溶液 溶血磷脂酰乙醇胺 溶血磷脂酰胆碱 高效液相色谱-蒸发光散射法 含量测定 |
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| 基金项目:南京市科技发展计划(201103025) |
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| Determination of Lyso-phosphatidylethanolamine and Lyso-phosphatidylcholine in Docetaxel Concentrated Solution for Injection |
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YANG Jun, XIE Jun
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Research Institute of Jinling Pharmaceutical Co., Ltd., Nanjing 210009, China
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| Abstract: |
| OBJECTIVE To develop an HPLC-ELSD method for the determination of lyso-phosphatidylcholine(LPC) and lyso-phosphatidylethanolamine(LPE) in Docetaxel Concentrated Solution for Injection. METHODS It was separated with YMC Pack PVA-Sil(150 mm×2 mm, 5 μm) by gradient elution with chloroform as mobile phase A and methanol-water (93.5∶6.5) as mobile phase B at a flow rate of 0.4 mL·min-1. The column temperature was kept at 25 ℃ for separation. The detector was ELSD, of which the drift tube temperature was maintained at 100 ℃ and the flow rate of carrier gas air was kept at 2.0 L·min-1. RESULTS The linear response was calculated by logarithm. The calibration curves were linear in the range of 0.203-0.811 μg(r=0.999 0) for LPE and 0.407-6.102 μg(r=0.999 6) for LPC. The average recovery for LPE was 104.1%, 95.1%, 101.6%, RSD=4.6%; and the average recovery for LPC was 108.7%, 104.5%, 105.5%, RSD=2.7%. CONCLUSION The established method is simple, accurate and reproducible, which can be used for the quality control of Docetaxel Concentrated Solution for Injection. |
| Key words: Docetaxel Concentrated Solution for Injection lyso-phosphatidylethanolamine lyso-phosphatidylcholine HPLC-ELSD content determination |
