Separation method for tirofiban hydrochloride isomer, and metering method for D-configuration tirofiban hydrochloride

A technology of tirofiban and a separation method is applied in the field of separation of tirofiban hydrochloride isomers, and can solve the problems of poor separation, poor accuracy, large errors and the like

Active Publication Date: 2013-01-16
通辽市华邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0015] The purpose of the present invention is to overcome the shortcomings of poor accuracy and large errors caused by poor resolution, high noise and other reasons in the method for separating and quantifying D-configuration tirofiban hydrochloride, and to provide a separation method with good accuracy and small errors. And the method for quantitative D configuration tirofiban hydrochloride

Method used

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  • Separation method for tirofiban hydrochloride isomer, and metering method for D-configuration tirofiban hydrochloride
  • Separation method for tirofiban hydrochloride isomer, and metering method for D-configuration tirofiban hydrochloride
  • Separation method for tirofiban hydrochloride isomer, and metering method for D-configuration tirofiban hydrochloride

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Embodiment 1

[0080] Use the chiral chromatographic column of ovomucin as the stationary phase; With 0.08% trifluoroacetic acid aqueous solution (regulating the pH value with triethylamine to be 3.0) the volume ratio of water phase and methanol is 99: 1 as mobile phase; 0.8ml per minute; detection wavelength is 230nm.

[0081] Under this condition, detect need testing solution, contrast solution and the detection spectrum that contrast substance solution obtains are similar to Figure 1-1A , Figure 1-1B with 1-1C . After replacing the organic phase with ethanol, isopropanol, acetonitrile or any combination of them, as long as other conditions remain unchanged, the detection results are similar.

Embodiment 2

[0083] Use the chiral chromatographic column of ovomucin as the stationary phase; the volume ratio of 0.10% trifluoroacetic acid aqueous solution (adjusting the pH value to 3.5 with triethylamine) and methanol is 85:15 as the mobile phase; the flow rate is 0.8 per minute ml; detection wavelength is 200nm.

[0084] Under this condition, detect need testing solution, contrast solution and the detection spectrum that contrast substance solution obtains are similar to Figure 1-2A , Figure 1-2B with 1-2C . After replacing the organic phase with ethanol, isopropanol, acetonitrile or any combination of them, as long as other conditions remain unchanged, the detection results are similar.

Embodiment 3

[0086] Use the chiral chromatographic column of ovomucin as the stationary phase; the volume ratio of 0.15% trifluoroacetic acid aqueous solution (adjusting the pH value to 4.0 with triethylamine) and methanol is 80:20 as the mobile phase; the flow rate is 0.8 per minute ml; detection wavelength is 227nm.

[0087] Under this condition, detect need testing solution, contrast solution and the detection spectrum that contrast substance solution obtains are similar to Figure 1-2A , Figure 1-2B with 1-2C . After replacing the organic phase with ethanol, isopropanol, acetonitrile or any combination of them, as long as other conditions remain unchanged, the detection results are similar.

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Abstract

The invention provides a separation method for tirofiban hydrochloride isomer, and a metering method for D-configuration tirofiban hydrochloride. By adjusting high performance liquid chromatography conditions, the separation flexibility of the tirofiban hydrochloride isomer is improved by 3 to 10 times, and the separation degree is improved to be more than 2.0, so that the accuracy of the D-configuration tirofiban hydrochloride is improved obviously.

Description

Technical field: [0001] The present invention relates to a kind of separation method of isomer and the quantitative method of D configuration isomer, specifically the present invention relates to a kind of separation method of tirofiban hydrochloride isomer and D configuration tirofiban hydrochloride quantitative method. Background technique: [0002] The chemical name of tirofiban is "N-(n-butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine". Tirofiban has the following chemical structure [0003] [0004] After tirofiban is salted, especially tirofiban hydrochloride, it has been widely used to treat patients with unstable angina or non-Q wave myocardial infarction, prevent cardiac ischemic events, and is also suitable for coronary ischemic syndrome coronary angioplasty or intracoronary atherectomy to prevent cardiac ischemic complications associated with sudden occlusion of the treated coronary artery. [0005] It can be seen from the above structural formula of tir...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D211/22G01N30/02
Inventor 闫志刚曹建英杨秀伟黄牧童张曦赜
Owner 通辽市华邦药业有限公司
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