Method for simultaneously detecting 2-pyrrolidone and formic acid in povidone K30
A technology for pyrrolidone and povidone, which is applied in the field of simultaneous detection of 2-pyrrolidone and formic acid in povidone K30, can solve the problem that the quality control of povidone K30 is not comprehensive and accurate, the subjective factors of the titration detection method are too large, and the detection items Many other problems, to achieve the effect of good precision and repeatability, high accuracy and wide linear range
Active Publication Date: 2016-03-23
贵州省欣紫鸿药用辅料有限公司
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[0002] According to the fourth part of the 2015 edition of the Pharmacopoeia of the People's Republic of China, the quality standard of povidone K30 is only for titration detection of the limit of N-vinylpyrrolidone. The titration detection method is too affected by subjective factors, which greatly affects the accuracy. influences
In addition, there is a lack of testing items for the content of 2-pyrrolidone in the standard, which leads to insufficient comprehensive and accurate quality control of povidone K30, which has become a hidden danger.
[0003] According to the United States Pharmacopoeia, the impurities required to be detected in the quality standards of povidone K30 include, N-vinylpyrrolidone, 2-pyrrolidone, formic acid, aldehyde, and peroxide. The first three impurities require liquid phase detection, and there are many detection items. , which is not conducive to the detection of a large number of samples
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[0024] Reference substance solution preparation: get 2-pyrrolidone reference substance and add water to make a solution of 25ug / ml, as the first reference substance solution, get formic acid reference substance and add water to make a 25ug / ml solution as the second reference substance, the first contrast solution Mix with the second control solution in a volume ratio of 1:1 to prepare a reference substance solution;
[0025] The preparation of need testing solution: get povidone K30 and add water and make the solution of 5mg / ml as need testing solution.
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The invention relates to a method for simultaneously detecting 2-pyrrolidone and formic acid, in particular to a method for simultaneously detecting the 2-pyrrolidone and formic acid in povidone K30. The method utilizes liquid chromatography to determine the content of the 2-pyrrolidone and the formic acid. The method utilizes the liquid chromatography to detect the 2-pyrrolidone and the formic acid, is high in accuracy, wide in linear range, strong in specificity, good in precision and repeatability and high in sensitivity, can provide a limit control basis for simultaneously detecting the content of the 2-pyrrolidone and the formic acid, can better control the quality of the povidone K30 and can effectively supervise production and ensure the stability of product quality and the medication safety of patients.
Description
technical field [0001] The invention relates to a method for simultaneously detecting 2-pyrrolidone and formic acid, in particular to a method for simultaneously detecting 2-pyrrolidone and formic acid in povidone K30. Background technique [0002] According to the fourth part of the 2015 edition of the Pharmacopoeia of the People's Republic of China, the quality standard of povidone K30 is only for titration detection of the limit of N-vinylpyrrolidone. The titration detection method is too affected by subjective factors, which greatly affects the accuracy. influences. In addition, the lack of testing items for the content of 2-pyrrolidone in the standard makes the quality control of povidone K30 not comprehensive and accurate, which becomes a hidden danger. [0003] According to the United States Pharmacopoeia, the impurities required to be detected in the quality standards of povidone K30 include, N-vinylpyrrolidone, 2-pyrrolidone, formic acid, aldehyde, and peroxide. Th...
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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 杨娴沈惠母泽波母瑞文民印卫东
Owner 贵州省欣紫鸿药用辅料有限公司