HPLC-ELSD法测定鸦胆子油乳注射液中4种磷脂成分的含量  

HPLC-ELSD determination of 4 phospholipids in Brucea javanica(L.) Merr. oil latex injection

作　　者：刘丹[1] 

机构地区：[1]中国医科大学附属第四医院,沈阳110032

出　　处：《中南药学》2015年第9期966-969,共4页Central South Pharmacy

摘　　要：目的建立HPLC-ELSD法测定鸦胆子油乳注射液中磷脂酰乙醇胺（PE）、溶血磷脂酰乙醇胺（LPE）、磷脂酰胆碱（PC）和溶血磷脂酰胆碱（LPC）的含量。方法采用Alltech Alltima C18硅胶色谱柱（4.6mm×250 mm,5μm）,以甲醇-水-冰醋酸-三乙胺（85：15：0.45：0.05,v/v/v）为流动相A,以正己烷-异丙醇-流动相A（20：48：32,v/v/v）为流动相B,进行梯度洗脱,流速为1.0 m L·min-1;柱温：40℃,进样量20μL。蒸发光散射检测器雾化气：氮气,雾化气流速：3.0 bar,漂移管温度：40℃,增益倍数：7。结果 4种磷脂成分分别在4.764-95.3μg·m L-1（r=0.999 3）、4.860-97.2μg·m L-1（r=0.999 9）、27.52-550.4μg·m L-1（r=0.999 1）和10.11-202.2μg·m L-1（r=0.999 1）与峰面积线性关系良好,低、中、高浓度回收率分别在96.5%-99.1%（RSD〈4.4%,n=3）、97.5%-98.8%（RSD〈3.7%,n=3）、96.5%-100.7%（RSD〈3.3%,n=3）和95.9%-98.7%（RSD〈3.7%,n=3）。结论此方法快速、准确、重复性好,可为鸦胆子油乳注射液的质量评价提供依据。Objective To establish an HPLC-ELSD method to determine phosphatidyl ethanolamine（PE）, lysophosphatidylethanolamine（LPE）, phosphatidyl choline（PC） and lysophosphatidylcholine id（LPC） in Brucea javanicaoil injection. Methods The sample was determined with Alltima C18 silica column（4.6 mm×250 mm, 5 μm） using methanol- water-glacial acetic acid- triethylamine（85 ：15 ：0.45 ：0.05, v/v/v） as mobile phase A, hexaneisopropyl alcohol-mobile phase A（20 ：48 ：32, v/v/v） as mobile phase B in the gradient elution. The flow rate was 1.0 m L·min- 1 and the column temperature was 40 ℃. Nitrogen was used as atomizing air for ELSD. The flow rate was 3.0 bar, and the drift tube temperature was 40 ℃. Results Good linearities of PE, LPE, PC and LPC in Brucea javanica oil injection were obtained at 4.764- 95.3 μg·m L- 1（r = 0.999 3）, 4.860- 97.2 μg·m L- 1（r = 0.999 9）, 27.52- 550.4 μg·m L- 1（r = 0.999 1） and 10.11- 202.2 μg·m L- 1（r = 0.999 1） respectively. The average recoveries of the 4 components were at 96.5%- 99.1%, 97.5%- 98.8%, 96.5%- 100.7% and 95.9%- 98.7%, and RSDs were less than 4.4%, 3.7%, 3.3% and 3.7% respectively. Conclusion This method is rapid and accurate with good repeatability. This method provides a reasonable basis for the safety evaluation of Brucea javanica oil injection.

关 键 词：鸦胆子油乳注射液 HPLC-ELSD 磷脂 含量测定 

分 类 号：R917[医药卫生—药物分析学]