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A method for determining residual isopropylamine in metoprolol succinate

A technology of metoprolol succinate and isopropylamine, applied in the field of medicine and chemical industry, can solve problems such as poor precision and accuracy

Inactive Publication Date: 2015-10-14
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method solves the problem of poor precision and accuracy of the analytical method caused by the adhesion of isopropylamine to the liner when the gas-phase headspace method is used to measure isopropylamine; at the same time, the acetone-water mixed solution of methanesulfonic acid can be used as the eluent well. Elute organic macromolecules, so that a large number of metoprolol succinate molecules will not remain and affect the precision and accuracy of repeated determination of isopropylamine

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  • A method for determining residual isopropylamine in metoprolol succinate
  • A method for determining residual isopropylamine in metoprolol succinate
  • A method for determining residual isopropylamine in metoprolol succinate

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Embodiment Construction

[0017] The method for measuring residual isopropylamine in the metoprolol succinate crude drug provided by the invention comprises:

[0018] a) Take the isopropylamine reference substance to be prepared into a reference substance solution, and inject 100 μl of it into an ion chromatograph, detect and record the peak area of ​​the chromatographic response;

[0019] b) Take the metoprolol succinate sample to be prepared into the test solution, and inject 100 μl of it into the ion chromatograph, detect and record the peak area of ​​the chromatographic response;

[0020] c) adopt external standard method to calculate the residual amount of isopropylamine in the metoprolol succinate sample;

[0021] Wherein the method is determined in an ion chromatograph using a cation exchange column and equipped with a conductivity detector.

[0022] The method of the present invention uses a cation-exchange chromatographic column for separation. The filler of the cation-exchange chromatographi...

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Abstract

The invention provides a method for determining the content of residual isopropylamine in metroprolol succinate bulk pharmaceutical chemicals, and relates to the field of pharmaceutical chemicals. According to the method, a chromatographic column taking carboxylic acid cation exchange resin as filler is adopted for an ion chromatograph, and a mixed solution of acetone of methanesulfonic acid and water acts as leacheate, so as to prepare an electrical conductivity detector for detection. The method provided by the invention can effectively control the residual amount of isopropylamine in metroprolol succinate bulk pharmaceutical chemicals, and has the characteristics of good specificity, high precision and accuracy in determination.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, and more specifically, relates to a detection method for determining residual isopropylamine in metoprolol succinate crude drug. Background technique [0002] Metoprolol succinate, chemical name: (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinic acid (2: 1) (salt). Its structural formula is as follows: [0003] [0004] Metoprolol succinate is a white or off-white crystalline powder. It is a selective β1 receptor blocker. It is one of the commonly used drugs for the treatment of hypertension, coronary heart disease, chronic heart failure and arrhythmia. It is mainly used for the treatment of Angina pectoris, raw material medicine for hypertension. The preparation method of the drug is known to the general public. For example, Chinese patent document CN 103102281 A discloses a preparation method of metoprolol succinate, and the product is also easily avail...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/64
Inventor 杨晓静
Owner SUNSHINE LAKE PHARM CO LTD