摘要
目的:建立测定注射用尖吻蝮蛇血凝酶的高效液相色谱分析方法。方法:采用Vydac 208TP54-C8(5μm,4.6 mm×250 mm)色谱柱,流动相A为0.1%三氟乙酸,B为乙腈-水(90∶10,含0.1%三氟乙酸),梯度洗脱,流速为0.8 mL·min-1,柱温45℃,检测波长为280 nm。结果:尖吻蝮蛇血凝酶浓度在2.5～30μg·mL-1(r=0.9991)范围内线性关系良好,平均回收率(n=9)为99.5%。结论:该方法可以为注射用尖吻蝮蛇血凝酶的质量控制提供依据。
Objective ：To establish an HPLC method for the determination of heamocoagulase agkistrodon for injec- tion. Methods ： The separation was performed on Vydae 208TP54 - C8 （5 μm,4. 6 mm × 250 mm） column with the mobile phase A of 0. 1% trifluoroacetic acid and B of 90% acetonitrile and water（90： 10,containing 0. 1% triflu- oroacetie acid） , at a flow rate of 0. 8 mL. min - 1 , with gradient elution. The column temperature was 45 ℃, and the detection wavelength was set at 280 nm. Results： The linear range was 2.5 - 30 μg . mL-1 （r = 0. 9991 ） for heamocoagulase agkistrodon. The average recovery （ n = 9 ） was 99.5 %. Conclusion： The method can provide a sci- entific basis for the quality control of heamoeoagulase agkistrodon for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第1期22-25,共4页
Chinese Journal of Pharmaceutical Analysis
基金
中国食品药品检定研究院中青年基金资助项目(No.2010A7)
