Method for detecting acetylcysteine and related substances thereof

Abstract

The invention relates to a method for detecting acetylcysteine and related substances thereof. The method adopts a high performance liquid chromatography, wherein the chromatographic condition is that styrene-divinylbenzene copolymer type superpolymer chromatographic column, namely MKF-RP-MH is 4 to 10 mu meters and (100-300)*(8.0-4.0) millimeters (I.D.); the volume ratio of phosphate buffer (pH is between 2 and 5) with mobile phase compositions of 0.01-0.05 mol / L to acetonitrile is 80-95:20-5; the flowing speed is between 0.8 and 1.2 mL / min; the detecting wavelength detected by an ultraviolet detector is 210nm; and the sample size is between 10 and 20 mu liters. The method does not use ionpairreagent, overcomes the defects that ODS column detecting method does not have acid resistance or low organic phase resistance when detecting the acetylcysteine.

Description

(1) Technical field

[0001] The invention relates to a high performance liquid chromatography (HPLC) detection method, in particular to a chromatographic column packed with a high polymer (ie, styrene-divinylbenzene copolymer, PS-DVB) chromatographic medium as a separation carrier to detect acetyl Analysis and detection method of cysteine ​​and its related substances. (2) Background technology

[0002] Acetylcysteine ​​is an essential amino acid for the synthesis of glutathione, an antioxidant containing sulfhydryl groups, and is used for the treatment of acute and chronic bronchitis and other lung diseases caused by sticky sputum. Acetylcysteine ​​can also be used in the treatment of HIV-infected patients to improve the physiology and immune function of patients with cysteine ​​deficiency caused by the virus.

[0003] Acetylcysteine ​​is easy to introduce related substances such as L-cystine, L-cysteine, N,N'-diacetylcystine and N,S-diacetylcystine during the production pro...