HPLC-ELSD法同时测定丙泊酚注射液中溶血磷脂酰胆碱和溶血磷脂酰乙醇胺的含量  

Simultaneous determination of lysophophatidyl choline and lysophosphatidyl ethanolamine in propofol injection by HPLC-ELSD

作　　者：陈华 于海洲 彭创业 

机构地区：[1]广东省食品药品检验所,广州510180 [2]烟台市食品药品检验所,264000 [3]广东嘉博制药有限公司,清远511517

出　　处：《药物分析杂志》2014年第3期442-446,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立HPLC—ELSD法同时测定丙泊酚注射液中溶血磷脂酰胆碱（LPC）和溶血磷脂酰乙醇胺（LPE）的含量。方法：采用UltimateDiol色谱柱（250mm×4．6mm，5μm），以甲醇-水-冰醋酸一三乙胺（85：15：0．5：0．05）为流动相A，以正己烷-异丙醇-流动相A（20：48：32）为流动相B，进行梯度洗脱，流速为1．0mL·min^-1，柱温为40℃。使用蒸发光散射检测器，雾化气为N2，载气压力为172kPa，漂移管温度为70℃。结果：溶血磷脂酰胆碱和溶血磷脂酰乙醇胺的浓度分别在0．02192-0．2192mg·mL^-1（r=0．9997）和0．01056～0．1mg·mL^-1（r=0．9980），呈良好的线性关系；检测下限分别为0．4μg和0．2μg；定量下限分别为0．8μg和0．6μg；平均回收率（n=9）分别为95．0％（RSD=1．3％）和94．0％（RSD％=1．1）。结论：本方法经方法学验证，可同时测定丙泊酚注射液中溶血磷脂酰胆碱和溶血磷脂酰乙醇胺的含量。Objective： To develop an HPLC - ELSD method for simultaneous determination of lysophosphatidyl choline （LPC） and lysophosphatidyl ethanolamine （LPE） in propofol Injection. Methods： The separation was per- formed on a Ultimate Diol column （250 mm× 4.6 ram,5 μm）. The gradient elution mobile phase consisted of two eluents ： methanol - water - glacial acetic acid - triethylamine （ 85： 15：0.5 ： 0. 05 ） as mobile phase A, n-hexane - isopropanol - mobile phase A （ 20：48： 32 ） as mobile phase B. The flow rate was 1.0 mL ~ rain - 1 at a temperature of 40 ℃. The detector was ELSD of which the drift tube temperature was maintained at 70 ℃ and the pressure of N2 was 172 kPa. Results： The linear response was calculated by natural logarithm. The calibration curves were linear in the range of 0. 02192 -0. 2192 mg· ml^-1for LPC （r =0. 9997） and 0. 01056 -0. 1 mg· mL-1 for LPE （r = 0. 9980）. The limit of detection was 0.4 μg for LPC and 0.2 μg for LPE. The limit of quantitation was 0.8μg for LPC and 0.6 txg for LPE. The average recoveries for LPC and LPE were 95.0% , and 94. 0% , and RSDs for LPC and LPE were 1.3 % and 1.1%, respectively. Conclusion： The method can be used for simultaneous determination of the content of LPC and LPE in propofol injection by methodology validation.

关 键 词：HPLC-ELSD法 丙泊酚注射液 溶血磷脂酰胆碱 溶血磷脂酰乙醇胺 有关物质测定 杂质控制 方法学验证 

分 类 号：R917[医药卫生—药物分析学]