Method for detecting trifluridine-related substance by high-performance liquid chromatography
申请人:TAIHO PHARMACEUTICAL CO., LTD.
公开号:US10816517B2
公开(公告)日:2020-10-27
The present invention provides a novel method that is capable of detecting a trifluridine-related substance from a sample containing trifluridine or a salt thereof by high-performance liquid chromatography comprising two steps that are performed under gradient conditions. More specifically, the method is for detecting a trifluridine-related substance, the method comprising the step of subjecting a sample containing trifluridine or a salt thereof to high-performance liquid chromatography using a mobile phase composed of an organic phase and an aqueous phase, wherein the step of high-performance liquid chromatography comprises steps 1 and 2 that satisfy the following requirements: Step 1: the percentage of the organic phase in the entire mobile phase is 1 to 14% by volume; and Step 2: after step 1, elution is performed by applying a gradient of increasing the percentage of the organic phase in the entire mobile phase.
本发明提供了一种新型方法,能够通过高效液相色谱法从含有三氟尿苷或其盐的样品中检测三氟尿苷相关物质,该方法包括在梯度条件下进行的两个步骤。更具体地说,该方法用于检测三氟尿嘧啶相关物质,该方法包括以下步骤:使用由有机相和水相组成的流动相,对含有三氟尿嘧啶或其盐的样品进行高效液相色谱分析,其中高效液相色谱分析步骤包括满足以下要求的步骤 1 和步骤 2:步骤 1:有机相在整个流动相中的比例为 1%至 14%(体积比); 步骤 2:在步骤 1 之后,通过增加有机相在整个流动相中的比例进行梯度洗脱。