摘要
目的：建立高效液相色谱法测定盐酸罗哌卡因中特定杂质的含量。方法：色谱柱为WondasilCl8（250mm×4．6nun，5μm1，流动相为甲醇-水-三氟乙酸（50：50：1），流速为0．4ml·min-1，ELSD载气流速为3．0ml／min，检测器飘移管温度为60℃，室温为30℃。结果：特定杂质在15-100μg／ml范围内的对数与峰面积对数有良好的线性关系（r2=0．9993，n=6），且该方法的平均回收率为99．1％，RSD为1．3％（n=9）。结论该方法简便，结果准确，可用于盐酸罗哌卡因中特定杂质的测定。
Objective To establish a method for the determination of the particular impurities in Ropivacaine hydrochloride by HPLC.Methods The determination was carried out on Wondasil C18column.The mobile phase was methanol-water- trifluoroacetic acid (50:50:1),the flow rate was 0.4ml·min-1 and the carrier gas flow rate of ELSD was 3.0ml·min-1, The temperature of detector drift tube was 60℃.Results The linear range of the particular impurities was 15~100μg/ml (r2=0.9993, n=6) .The average recovery was 99.1% and the RSD was 1.3%.Conclusion This method was simple,accurate and can be used for the determination of the particular impurities.
出处
《中国化工贸易》
2013年第9期220-220,共1页
CHINA CHEMICAL TRADE
