Method for analyzing related substances of sulfadoxine

Abstract

The invention discloses a sulfadoxine related substance analysis method which comprises the following steps: 1) preparing an applicable solution: taking about 10mg of sulfanilamide sodium, about 10mg of chloride, about 10mg of condensation compound, about 10mg of impurity A, about 10mg of impurity B, about 10mg of impurity C, about 10mg of 4-amino-5, 6-dimethoxypyrimidine and about 10mg of sulfanilic acid, precisely weighing, respectively putting into 10ml measuring flasks, firstly adding 4ml of acetonitrile, then dissolving and diluting with a mobile phase to a scale, uniformly shaking, and measuring the content of sulfanilamide sodium, chloride, condensation compound, impurity A, impurity B, impurity C, 4-amino-5, 6-dimethoxypyrimidine and sulfanilic acid; taking as an impurity stock solution A; respectively and precisely measuring 1.0 ml of the impurity stock solution A into a 100ml measuring flask, diluting to a scale by using a mobile phase, and uniformly shaking to obtain an impurity stock solution B; and precisely measuring 2.5 ml of the impurity stock solution B, adding the impurity stock solution B into a 50ml measuring flask, precisely weighing about 25mg of sulfadoxine, adding the sulfadoxine into the 50ml measuring flask, adding 20ml of acetonitrile, carrying out ultrasonic treatment to dissolve the sulfadoxine, diluting with a mobile phase to a scale, and uniformly shaking to obtain the sulfadoxine-containing organic impurity detection reagent.

Description

technical field [0001] The invention relates to the technical field of chemical drug analysis methods, in particular to a sulfadoxine related substance analysis method. Background technique [0002] Sulfadoxine is obtained through the organic synthesis process. During the whole synthesis process, due to the existence of impurities in the starting materials, various side reactions and by-products, the composition of organic impurities is quite complicated. The existing related substance analysis methods are: Thin-layer chromatography, but the sensitivity of thin-layer chromatography is relatively low, the method of observing the results by visual observation is somewhat subjective, and it is easy to introduce human errors, and the expansion distance of the thin-layer plate is limited, and the separation situation cannot be optimal. Therefore, we propose a method for the analysis of sulfadoxine related substances. SUMMARY OF THE INVENTION [0003] The technical problem to b...

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Problems solved by technology

[0002] Sulfadoxine is obtained through an organic synthesis process. During the entire synthesis process, due to the presence of impurities in the starting materials, various side reactions and by-products, the composition of organic impurities is quite complicated. Currently, the existing methods for the analysis of related substances are Thin-layer chromatography, but the sensitivity of thin-layer chromatography is relatively low, and the method of visually observing the results is somewhat subjective, which is easy to introduce human error, and the expansion distance of the thin-layer plate is limited, and the separation cannot be optimal. Therefore, we propose a method for the analysis of related substances of sulfadoxine

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