Novel detecting method for docusate sodium content and relevant substance

Abstract

The invention discloses a novel detecting method for the docusate sodium content and a relevant substance. The relevant substance is 2-ethylhexyl ester. The method includes the following steps of preparing a reference substance solution A and a test article solution B, injecting 20 microliters of a sample of the reference solution A and 20 microliters of a sample of the test article solution B, recording the peak area of docusate sodium in a chromatogram, calculating the HPLC content through anhydrous docusate sodium according to an external standard method, preparing an impurity reference substance solution C and a test article solution D, injecting 20 microliters of a sample of the impurity reference solution C and 20 microliters of a sample of the test article solution D, recording the peak areas of docusate sodium and 2-ethylhexyl ester in the chromatogram, and calculating the content of docusate sodium and the limit of the relevant substance, namely 2-ethylhexyl ester, and other total impurities in the docusate sodium sample according to the external standard method. By means of the method, under isocratic liquid phase spectrum conditions, docusate sodium and the relevant substance like DK10 can be effectively separated, and the content of docusate sodium and the limit of the relevant substance like DK10 can be accurately and quantitatively detected, detection cost is low, and detection efficiency is high.

Description

technical field [0001] The invention relates to a new detection method for docusate sodium content and related substances. Background technique [0002] Docusate sodium is a drug clinically used to treat chronic functional constipation, and it is also used as a food additive in the United States and Europe. The chemical name of docusate sodium is 2-ethylhexyl sodium salt, which has been included in the European Pharmacopoeia, the United States Pharmacopoeia and other national pharmacopoeias. Chronic functional constipation is one of the more common gastrointestinal diseases in clinical practice, which is caused by the abnormal function of the colon, rectum and anus, resulting in decreased stool frequency or intractable dry stool. Local and general discomfort Chronic constipation can cause local and systemic symptoms, such as bitter mouth, sticky mouth, epigastric fullness, hypochondriac pain, belching, and some patients may also experience loss of appetite, listlessness, di...

AI Technical Summary

Problems solved by technology

Compared with the isocratic liquid phase detection method, the high-pressure gradient liquid phase detection method has disadvantages such as poor reproducibility, easy interference by ghost peaks in the mobile phase, and high detection cost.

Therefore, for the intermediate product control of industrialized production of docusate sodium and the detection of docusate sodium finished products, there is very great inconvenience, and it is impossible to effectively and accurately monitor the residue limits of various related substances and docusate sodium in the production process of docusate sodium. The quality of sodium final product

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