Method for determining content of (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate

A technology of ethyl crotonate and imino group, applied in the field of medicine, can solve problems such as no reports

Pending Publication Date: 2022-04-22
王立强
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, in the prior art, there is no report on the content determination method of "(2E,4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester"
The present invention aims to solve the problem of detecting the related substance "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" before leaving the factory or using minodronic acid hydrate , providing a convenient, accurate, efficient and inexpensive detection method

Method used

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  • Method for determining content of (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate
  • Method for determining content of (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate

Examples

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Embodiment 1

[0047] A method for determining the content of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester", comprising the steps of:

[0048] (1) Preparation of reference substance: Accurately weigh 5 mg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" and dissolve it in mobile phase Finally, put it in a 100 mL volumetric flask, add mobile phase to dilute to the mark, and prepare a reference substance mother solution with a concentration of 50 μg / mL, take 1 mL of the reference substance mother solution in a 10 mL volumetric flask, and dilute to the mark with mobile phase , configured as a reference substance solution containing 5 µg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" per 1 ml;

[0049] (2) Preparation of the test sample: Accurately weigh 25 mg of minodronic acid hydrate, add 4 g / L sodium hydroxide solution to dissolve, sonicate for 5 min, let cool to room temperature, place in a 50 mL measuring bottle, Add mobile ...

Embodiment 2

[0056] A method for determining the content of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester", comprising the steps of:

[0057] (1) Preparation of reference substance: Accurately weigh 5 mg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" and dissolve it in mobile phase Finally, put it in a 100 mL volumetric flask, add mobile phase to dilute to the mark, and prepare a reference substance mother solution with a concentration of 50 μg / mL, take 1 mL of the reference substance mother solution in a 10 mL volumetric flask, and dilute to the mark with mobile phase , configured as a reference substance solution containing 5 µg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" per 1 ml;

[0058] (2) Preparation of the test sample: Accurately weigh 25 mg of minodronic acid hydrate, add 4 g / L sodium hydroxide solution to dissolve, sonicate for 5 min, let cool to room temperature, place in a 50 mL measuring bottle, Add mobile ...

Embodiment 3

[0065] A method for determining the content of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester", comprising the steps of:

[0066] (1) Preparation of reference substance: Accurately weigh 5 mg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" and dissolve it in mobile phase Finally, put it in a 100 mL volumetric flask, add mobile phase to dilute to the mark, and prepare a reference substance mother solution with a concentration of 50 μg / mL, take 1 mL of the reference substance mother solution in a 10 mL volumetric flask, and dilute to the mark with mobile phase , configured as a reference substance solution containing 5 µg of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester" per 1 ml;

[0067] (2) Preparation of the test sample: Accurately weigh 25 mg of minodronic acid hydrate, add 6 g / L sodium hydroxide solution to dissolve, sonicate for 5 min, let it cool to room temperature, put it in a 50 mL measuring bottle, Add mob...

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Abstract

The invention discloses a method for determining the content of (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate, which comprises the following steps of: preparing a (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate reference substance into a reference substance solution with the concentration of 5mu g/mL, and measuring the content of the (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-ethyl crotonate. Preparing a minodronic acid hydrate test solution with the concentration of 500mu g/mL from a raw material medicine sample of the minodronic acid hydrate, and finally, precisely sucking the reference substance solution and the test solution respectively, injecting the reference substance solution and the test solution into a high performance liquid chromatograph, and measuring; the determination method disclosed by the invention is convenient, accurate and reliable, and the content of the ethyl (2E, 4E)-ethyl-4-(pyridine-2-yl imino)-2-butenoate in the product can be really reflected.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for determining the content of "(2E, 4E)-ethyl-4-(pyridin-2-ylimino)-2-butenoic acid ethyl ester". Background technique [0002] Minodronic acid hydrate is 1-hydroxy-2-(imidazo[1,2-a]pyridin-3-yl)ethane-1,1-bisphosphonic acid monohydrate with a molecular weight of 340.16 g / mol, the molecular formula is C 9 h 12 N 2 o 7 P 2 ·H 2 O; Minodronic acid hydrate, an orally bioavailable third-generation bisphosphonate with significant efficacy in the treatment of osteoporosis. Bisphosphonates are artificially synthesized non-biodegradable pyrophosphate analogues, which are jointly developed by Japan's Yamanouchi Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd. At present, in non-clinical trials, minodronic acid hydrate shows good anti-bone resorption ability, inhibition of bone mineral density and reduction of bone strength with only a lower dose than the existing bicarbon...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634
Inventor 王立强
Owner 王立强
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