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盐酸罗哌卡因中特定杂质的测定

         

摘要

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.%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Wondasil C18(250mm×4.6mm,5μm),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。

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