Determination of Related Substances in Thioctic Acid Injection by HPLC / 中国药房
China Pharmacy
;
(12): 2980-2982, 2016.
Article
in Chinese
| WPRIM
| ID: wpr-504710
ABSTRACT
OBJECTIVE:
To establish a method for the determination of related substances in Thioctic acid injection. METH-ODSHPLC was performed on the column of Agilent Eclipse Plus C18 with mobile phase A of 0.005 mol/L potassium dehydroge-nate phosphate solution(adjusted with phosphoric acid to pH 3.0 to 3.1)and B of methanolaoetonitrile(1∶1,V/V)(gradient elu-tion) at a flow rate of 1.2 ml/min;detection wavelength was 215 nm,column temperature was 35 ℃,and the injection volume was 20 μl.RESULTS:
Under the established chromatographic conditions,thioctic acid with impurities and its degradation products were well separated;the linear range of thioctic acid was 0.828-52.992 μg/ml(r=0.999 9);RSDs of precision and stability tests were lower than 3%;recovery of impurity A was 98.45%-105.73%(RSD=2.41%,n=9);the largest single impurity content in mass fraction was 0.152%-0.189%,the total impurity content in mass fraction was 0.487%-0.516%.CONCLUSIONS:
The meth-od is simple,accurate,specific and sensitivity,and can be used to determine the related substances of the Thioctic acid injection.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2016
Type:
Article
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