Method for detecting related substances of 4-Boc-aminopiperidine

A related substance, aminopiperidine technology, which is applied in the detection field of 4-Boc-aminopiperidine related substances, can solve the problems of unrecorded 4-Boc-aminopiperidine detection methods, etc., and achieve high sensitivity and good reproducibility , Improve the effect of drug safety

Active Publication Date: 2021-11-05
HEBEI GUOLONG PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, at present, the pharmacopoeias of various countries do not include the detection methods of related substances of 4-Boc-aminopiperidine

Method used

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  • Method for detecting related substances of 4-Boc-aminopiperidine
  • Method for detecting related substances of 4-Boc-aminopiperidine
  • Method for detecting related substances of 4-Boc-aminopiperidine

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Embodiment 1

[0033] The embodiment of the present invention provides a method for detecting related substances of 4-Boc-aminopiperidine

[0034] 1.1 Materials and methods

[0035] Instruments: gas chromatograph, hydrogen flame ionization detector, measuring bottle, electronic balance.

[0036] Blank solvent: methanol.

[0037] 1.2 Preparation of solution

[0038] Reference substance solution: Take an appropriate amount of 4-amino-1-ethoxycarbonylpiperidine, 4-Boc-amino-1-ethoxycarbonylpiperidine and 4-aminopiperidine, weigh them accurately, and make each 1mL reference substance with methanol The methanol solution contained 250 µg of 4-amino-1-ethoxycarbonylpiperidine, 250 µg of 4-Boc-amino-1-ethoxycarbonylpiperidine, and 250 µg of 4-aminopiperidine.

[0039] The test solution: take an appropriate amount of 4-Boc-aminopiperidine, accurately weighed, and make each 1mL methanol solution of the test contains 10 mg of the 4-Boc-aminopiperidine.

[0040] 1.3 Detection method for related subs...

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Abstract

The invention relates to the technical field of drug analysis and detection, and particularly discloses a method for detecting related substances of 4-Boc-aminopiperidine. According to the method, the related substances are determined by adopting a gas chromatographic method. The chromatographic conditions are as follows: a chromatographic column is a capillary column taking dimethyl polysiloxane as a stationary liquid; the flow velocity of a carrier gas is 2.0-4.0 ml / min; the split ratio is (5-10): 1; in a heating procedure, the initial temperature is 45-55 DEG C and maintained for 3-5 minutes, and the temperature is increased to 180-220 DEG C at the speed of 10-15 DEG C per minute and maintained for 3-5 minutes; the temperature of a sample inlet is 160-200 DEG C; and a detector is a hydrogen flame ionization detector, and the temperature of the detector is 240-260 DEG C. According to the detection method provided by the invention, effective separation of the 4-Boc-aminopiperidine and the related substances of the 4-Boc-aminopiperidine can be realized, and the content of the related substances in the 4-Boc-aminopiperidine can be accurately detected. The method is sensitive, accurate and good in reproducibility, provides reliable guarantee for improving and better controlling the quality of 4-Boc-aminopiperidine, and also has very important significance for improving medication safety.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a detection method for related substances of 4-Boc-aminopiperidine. Background technique [0002] Prucalopride Succinate is a benzoimidazole drug with the chemical name 4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl) -4-piperidinyl]-7-benzofuran carboxamide succinate is a specific 5-HT4 receptor full agonist with high selectivity and specificity for 5-HT4 receptor agonism. The results of in vivo and in vitro studies show that prucalopride succinate can enhance the peristaltic reflex and propulsive motor pattern in the gastrointestinal tract through 5-HT4 receptor activation, and is mainly used for the treatment of various constipation and postoperative gastrointestinal motility weakness and Pseudo-obstruction. It has a good curative effect in the treatment of chronic constipation, can effectively improve the symptoms of patients and restore normal intest...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/30G01N30/32G01N30/60
CPCG01N30/02G01N30/32G01N30/30G01N30/6052G01N2030/047G01N2030/324
Inventor 杨俊免宗莹莹陈碧楚孙朝利毕贺王肖安淼季妍胡硕耿玉董博
Owner HEBEI GUOLONG PHARMA CO LTD
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