A kind of detection method of 4-boc-aminopiperidine related substance
A related substance, aminopiperidine technology, applied in the detection field of 4-Boc-aminopiperidine related substances, can solve the problem of not including 4-Boc-aminopiperidine detection method and the like, achieve high sensitivity and good reproducibility , improve the effect of drug safety
Active Publication Date: 2022-04-08
HEBEI GUOLONG PHARMA CO LTD
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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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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 specifically discloses a detection method for related substances of 4-Boc-aminopiperidine. The present invention uses gas chromatography to measure related substances, and the chromatographic conditions are: chromatographic column: capillary column with dimethylpolysiloxane as the stationary liquid; carrier gas flow rate: 2.0-4.0ml / min; split ratio: 5-10 : 1; heating program: initial temperature 45-55°C, maintain 3-5 minutes, heat up to 180-220°C at a rate of 10-15°C per minute, maintain 3-5 minutes; inlet temperature: 160-200 °C; the detector is a hydrogen flame ionization detector, and the detector temperature is 240-260 °C. The detection method provided by the invention can effectively separate 4-Boc-aminopiperidine from related substances of 4-Boc-aminopiperidine, and accurately detect the content of related substances in 4-Boc-aminopiperidine. Moreover, the method of the present invention is sensitive, accurate and reproducible, provides a reliable guarantee for improving and better controlling the quality of 4-Boc-aminopiperidine, and is also of great significance for improving drug 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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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