Identification of Impurities in Succinylcholine Chloride Raw Material by Two-dimensional UPLC-QTOF-MS
10.6039/j.issn.1001-0408.2018.07.19
- VernacularTitle:二维超高效液相色谱-飞行时间质谱联用技术鉴定氯化琥珀胆碱原料药中的杂质
- Author:
Hong CHEN
1
;
Mei YANG
;
Hengjie ZHANG
;
Ming YUAN
;
Xiangjin LIAN
Author Information
1. 成都市食品药品检验研究院
- Keywords:
Succinylcholine chloride;
Raw material;
Impurity;
Two-dimensional UPLC-QTOF-MS
- From:
China Pharmacy
2018;29(7):941-944
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish the method for the identification of impurities in succinylcholine chloride raw material. METHODS:Two-dimensional UPLC-QTOF-MS was adopted. One dimension chromatographic condition was Hypersil GOLD C18 column using buffer solution(22 mmol/L sodium pentanesulfonate+50 mmol/L sodium chloride+5 mmol/L sulphuric acid)as mobile phase A and acetonitrile as mobile phase B,volume ratio of mobile phase A to mobile phase B 95:5,column temperature of 40 ℃,flow rate of 1.0 mL/min,detection wavelength of 214 nm. Two-dimension chromatographic condition was ACQUITY UPLC BEH C18column using 0.1% ammonia as mobile phase A and acetonitrile as mobile phase B(gradient elution)with column temperature of 30 ℃ at flow rate of 0.4 mL/min. Ionization mode was ESI+ with capillary voltage of 2.5 kV,source temperature of 120 ℃,temperature of atomizing gas at 450 ℃,flow rate of atomizing gas at 900 L/h,acquisition mode of MSE. RESULTS:The succinic acid,succinyl chloride(intermediate),pyridine(reagent)and other impurities were detected in succinylcholine chloride by one dimensional method of HPLC. Other 4 obvious unknown impurities were named impurity 1,impurity 2,impurity 3 and impurity 4,among which the apparent content of impurity 2 was the highest. Two-dimensional method of HPLC-QTOF-MS deduced that the impurity 2 was dehydrogenate succinylcholine chloride and impurity 4 was succinylcholine chloride. The impurity 1 and impurity 3 were not detected in mass spectrum. CONCLUSIONS:Establish method for the identification of impurity in succinylcholine chloride raw material,and the results of research are used for the evaluation of the quality of the succinylcholine chloride raw material.
