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A kind of detection method and application of 3-quinuclidinone hydrochloride

A quinuclidine hydrochloride and detection method technology, applied in the field of medicinal chemistry, can solve the problems of complicated operation, low recovery rate and precision, poor stability and repeatability, etc., and achieves good repeatability, remarkable recovery rate, good stability

Active Publication Date: 2022-07-22
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] The existing detection method for this impurity is complex in operation, its stability and repeatability are poor, and the recovery rate and precision are low. Therefore, the present invention has established a new method with high stability, good repeatability and practicality. Strong, simple and convenient method for quantitative detection of 3-quinuclidinone hydrochloride in penehyclidine hydrochloride

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  • A kind of detection method and application of 3-quinuclidinone hydrochloride
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  • A kind of detection method and application of 3-quinuclidinone hydrochloride

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Embodiment 1

[0031] Embodiment 1-In order to quantitatively detect 3-quinuclidine hydrochloride in penehyclidine hydrochloride, the present invention proposes a detection method for 3-quinuclidine hydrochloride, comprising the following steps:

[0032] Prepare the sample solutions to be tested: 3-quinucridone hydrochloride reference solution and penehyclidine hydrochloride test solution, and inject the same amount into a high-performance chromatograph for measurement. The measurement conditions include: chromatographic column: benzene Base column, column length (4.4~4.8)mm×300mm, particle size of filler 4~6μm; mobile phase is 0.2~1% difluoroacetic acid solution: acetonitrile=95:5, flow rate is 0.2~0.5ml / min, column temperature The temperature is 25-30°C, the detector is a differential refractive index detector, and the temperature of the detection cell of the differential refractive index detector is 35-45°C.

Embodiment 2

[0033] Embodiment 2-a kind of detection method of 3-quinuclidone hydrochloride, comprises the steps:

[0034] (1) Preparation of 3-quinucridone hydrochloride reference solution:

[0035] Weigh 3-quinuclidinone hydrochloride reference substance and mix it with mobile phase, mobile phase is 0.2% difluoroacetic acid solution: acetonitrile=95:5, in g / L by mass volume ratio, 3-quinucridone salt Salt reference substance: the ratio of the mobile phase is 0.01:1000, and it is prepared into 3-quinuclidinone hydrochloride reference substance solution for use;

[0036] (2) Preparation of penehyclidine hydrochloride test solution

[0037] Weigh the penehyclidine hydrochloride sample and mix it with the mobile phase, the mobile phase is 0.2% difluoroacetic acid solution: acetonitrile=95:5, in g / L by mass-volume ratio, the penehyclidine hydrochloride sample: the ratio of the mobile phase is 0.01:1, prepared into penehyclidine hydrochloride test solution for use;

[0038] (3) draw the ref...

Embodiment 3

[0039] Embodiment 3-a kind of detection method of 3-quinuclidone hydrochloride, comprises the steps:

[0040] (1) Preparation of 3-quinucridone hydrochloride reference solution:

[0041] Weigh 3-quinuclidinone hydrochloride reference substance and mix it with mobile phase, mobile phase is 1% difluoroacetic acid solution: acetonitrile=95:5, in g / L by mass volume ratio, 3-quinuclidinone salt Salt reference substance: the ratio of the mobile phase is 0.1:1000, and it is prepared into 3-quinuclidine hydrochloride reference substance solution for use;

[0042] (2) Preparation of penehyclidine hydrochloride test solution

[0043] Weigh the penehyclidine hydrochloride sample and mix it with the mobile phase, the mobile phase is 1% difluoroacetic acid solution -: acetonitrile = 95:5, calculated in g / L by mass volume ratio, penehyclidine hydrochloride sample: ratio of mobile phase 0.1:1, prepared into penehyclidine hydrochloride test solution for use;

[0044](3) draw the reference ...

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Abstract

The present invention provides a method for detecting 3-quinuclidinone hydrochloride. The sample solutions to be tested are respectively prepared, and the same amount is drawn and injected into a high-efficiency chromatograph for measurement. 4.8) mm×300mm, particle size of filler 4~6μm; mobile phase 0.2~1% difluoroacetic acid solution: acetonitrile=95:5, flow rate 0.2~0.5ml / min, column temperature 25~30℃, detector is differential refraction Detector; the invention realizes the quantitative detection of 3-quinuclidine hydrochloride in penehyclidine hydrochloride, and has the advantages of good stability, good repeatability, high precision and remarkable recovery rate. During the detection process, the RSD of the solution stability within 8 hours was 0.8%; the RSD of the repeatability was 0.18%; the RSD of the precision was 0.25%, the recovery rate was higher than 99.0%, the applicability was strong, and the operation was simpler and more convenient.

Description

technical field [0001] The invention relates to the technical field of medicinal chemistry, in particular to a detection method and application of 3-quinuclidinone hydrochloride. Background technique [0002] Impurities in pharmaceuticals are usually the residues and by-products or degradation products of starting materials, which have a great impact on pharmacodynamics, pharmacokinetics, and pharmacology and toxicology. How to accurately quantify impurities becomes the key to control impurities in pharmaceuticals. prerequisites. Effective and accurate impurity detection methods can accurately quantify impurities and effectively control impurities. [0003] Penehyclidine hydrochloride, chemical name: 3-(2-cyclopentyl-2-hydroxy-2-phenylethoxy) quinuclidine hydrochloride. The chemical formula is: [0004] [0005] Penehyclidine hydrochloride is a highly selective anticholinergic drug, and its injection is a new anticholinergic drug pioneered by Youji jointly developed by...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74
Inventor 赵宇夏中宁
Owner 北京鑫开元医药科技有限公司
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