Determination of related substances of 15 drugs by the identical UPLC-MS/MS method
10.19778/j.chp.2025.04.011
- VernacularTitle:同一种UPLC-MS/MS方法测定15种药物的有关物质
- Author:
Yun LIU
1
;
Xiang GAO
1
;
Chenxue ZHAO
1
;
Pei LI
1
;
Yuzhong YANG
1
Author Information
1. 新乡市食品药品检验所,河南新乡 453000
- Publication Type:Journal Article
- Keywords:
UPLC-MS/MS;
related substances;
content determination;
antihypertensive drug;
hypoglycemic drug;
lipid-lowering drug
- From:
Drug Standards of China
2025;26(4):404-410
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an identical UPLC-MS/MS method for determination of related substances of 15 drugs(bezafibrate,acipimox,gliquidone,glimepiride,glipizide,glibenclamide,enalapril,captopril,irbesartan,amlodipine,felodipine,nimodipine,nitrendipine,nisoldipine,nifedipine).Methods:The chromatography was performed on Waters ACQUITY UPLCHSS T3(2.1 mm × 100 mm,1.8 μm)column,mobile phase was 0.01 mmol·L-1 Ammonium formate solution containing 0.1％formic acid and methanol with gradient elution.The flow rate was 0.3 mL·min-1,and the injection volume was 2 μL.The detection was carried out by electrospray ioniza-tion(ESI).Multiple-reaction monitoring(MRM)was employed with switching electrospray ion source polarity in positive and negative mode.Results:The 21 related substances showed good linearity(r ≥0.998 35)in the tested ranges.The precision(RS D≤3.45％)and stability(RSD≤3.48％)of the method were good for the related sub-stances.The average recoveries of the related substances were in the range of 91.81％-101.84％with relative standard deviations RSD≤4.66％.Conclusion:The method is rapid,simple,accurate and highly sensitive,and can be used as a auxiliary test method and confirmatory method for current drug standards.
