HPLC法测定恶拉戈利钠中间体6有关物质及方法学验证
HPLC Determination of Related Substances of Elagolix Sodium Intermediate 6 and Validation of Analytical Method
王武宝 1高思国 1刘水莲 1张雨 1任耀辉 1时呈凤 1范荣荣1
作者信息
- 1. 济南尚博医药股份有限公司,山东 济南 250204
- 折叠
摘要
目的:建立了测定恶拉戈利钠中间体 6 有关物质的HPLC法,并进行方法学验证.方法:用WATREX Reprosil C18(4 mm×250 mm×5 μm)色谱柱,以0.1%磷酸水为流动相A,甲醇为流动相B,进行梯度洗脱,流速 1.1 mL/min;用紫外检测器检测,波长 215 nm;进样量15 μL;柱温25℃.结果:恶拉戈利钠中间体6 与其他各中间体分离度好,线性、溶液稳定性、重复性及中间精密度试验结果均符合要求,各中间体的控制限度均可达到定量限.结论:本高效液相色谱法专属性强、灵敏度高、精密度好、方法操作简单、准确,可用于恶拉戈利钠中间体 6 有关物质的测定.
Abstract
Objective:The HPLC method was established for the detection of related substances of elagolix sodium intermediate 6 and validation of analytical method.Method:The WATREX reprosil C18(4 mm×250 mm×5 μm)was used and mobile phase A was 0.1%phosphoric acid in water,the mobile phase B was methanol with gradient elution method at a flow rate of 1.1 mL/min,the UV detector was used with 215 nm,sample injection volume was 15 μL,column temperature was 25℃.Result:Elagolix intermediate 6 is well separated from other intermediates.The results of linearity,solution stability,repeatability and intermediate precision are all meet the requirements.The control limits of each intermediate can all reach its LOQ.Conclusion:The HPLC method has strong specificity,high sensitivity,good precision,simple and high accuracy,and can be used for the determination of related substances of elagolix sodium intermediate 6.
关键词
HPLC法/恶拉戈利钠中间体6/有关物质/方法学验证Key words
HPLC method/elagolix sodium intermediate 6/related substances/validation of analytical method引用本文复制引用
出版年
2024
NETL
NSTL
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