甲磺酸托烷司琼含量测定

Content Determination of Methanesulfonic Acid Tropisetron

目的:建立高效液相色谱法对甲磺酸托烷司琼注射液进行含量测定。方法:色谱柱为Kromasil 100-5C18(250 nm×4.6 nm,5μm),以甲醇-水-乙腈-三乙胺(750:200:50:0.2)为流动相;流速为1.0 ml/min;检测波长为284nm。结果:甲磺酸托烷司琼检测量在1.6～2.4μg范围内,与色谱峰面积线性关系良好,Y=2 547.2X+3.456,r=1;准确度试验中回收率为99.99%(RSD=0.51%,n=9)。结论:本文建立的含量测定方法快速、准确、重现性好,含量测定HPLC检查方法专属性强、灵敏度高,可用于甲磺酸托烷司琼注射液的质量控制。

Objective：To establish the content determination method of methanesulfonic acid tropisetron injecta through HPLC.Method： Chromatographic column： Kromasil 100-5C18（250 nm×4.6 nm,5 μm）,mobile： the mixture of methanol,water,acetonitrile,triethylamine（750：200：50：0.2, V/V/V/V）;flow rate： 1.0 ml/min;detection： 284 nm.Result： The linear relation of chromatographic peak area was better in the detection extent from 1.6 to 2.4 μg,which was Y=2 547.2X＋3.456,r=1;the recovery was 99.9%（RSD=0.51%,n=9） in accuracy experiment.Conclusion：The test method established is applied to quality control in methanesulfonic acid tropisetron injecta which is characterized by quick,accurate,well in repeatability,high HPLC specificity and sensitive.