Content Determination of Related Substances in Terlipressin for Injection by UPLC
- VernacularTitle:UPLC法测定注射用特利加压素中有关物质的含量
- Author:
Qiaoru XUE
1
;
Jinye YUAN
1
;
Liuyang DING
1
;
Weijun ZHENG
1
;
Feng DENG
1
Author Information
1. Guangdong Institute for Drug Control/ NMPA Key Laboratory of Quality Control of Blood Products/Key Laboratory of Quality Control and Research of Blood Products,Guangzhou,510663,China
- Publication Type:Journal Article
- Keywords:
UPLC;
Terlipressin for injection;
Related substance;
Content determination
- From:
China Pharmacy
2020;31(9):1108-1112
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish UPLC method for the content determination of related substances in Terlipressin for injection. METHODS :UPLC method was used to determine the contents of related substances in 5 batches of Terlipressin for injection. The separation was performed on Xtimate UPLC C 18 column with mobile phase A consisted of ammonium sulfate buffer (pH 2.3)-methanol(90 ∶ 10,V/V)and mobile phase B consisted of ammonium sulfate buffer (pH 2.3)-methanol(60 ∶ 40,V/V) (gradient elution )at the flow rate of 0.2 mL/min. The detection wavelength was set at 210 nm,and sample size was 5 μL. RESULTS:The linear range of impurity A ,B,C,D,F,H,I,K,L and N were 0.43-3.86,0.44-3.95,0.44-3.97,0.45-4.08, 0.45-4.05,0.50-4.50,0.47-4.26,0.47-4.23,0.46-4.13,0.44-3.96 μg/mL(r≥0.999 7),respectively. The detection limits were 0.04, 0.04,0.05,0.04,0.05,0.05,0.05,0.05,0.04 μg/mL. The quantitation limits were 0.13,0.13,0.14,0.13,0.15,0.14,0.14, 0.14,0.13 μg/mL,respectively. RSDs of precision ,reproducibility and stability tests were all lower than 8%. The average recoveries were 94.95%,97.81%,101.88%,95.26%,93.40%,102.48%,104.26%,102.31%,96.42%,90.42%,with RSD s of 1.89%,1.86%,0.68%,1.30%,1.98%,3.36%,1.26%,1.30%,1.19%,1.40%(n=9),respectively. Total contents of impurities in 5 batches of Terlipressin for injection were all lower than 4%. CONCLUSIONS :Established method is rapid ,simple, accurate and specific ,which can be used for the quantitative analysis for related substances in Terlipressin for injection.