HPLC Determination of Related Substances of Elagolix Sodium Intermediate 6 and Validation of Analytical Method
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.
HPLC methodelagolix sodium intermediate 6related substancesvalidation of analytical method
NETL
NSTL
万方数据
