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Method for detecting related substances of sarpogrelate hydrochloride intermediate

A technology of sarcogrelate hydrochloride and intermediates, which is applied in the field of detection of related substances containing sarcogrelate hydrochloride intermediate C

Active Publication Date: 2018-06-26
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, there is no public research on the detection method of intermediate C related quality indicators

Method used

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  • Method for detecting related substances of sarpogrelate hydrochloride intermediate
  • Method for detecting related substances of sarpogrelate hydrochloride intermediate
  • Method for detecting related substances of sarpogrelate hydrochloride intermediate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0146] Embodiment 1 Intermediate C Related Substance Detection

[0147] Chromatographic conditions:

[0148] Filler with octadecylsilane bonded silica gel;

[0149] Mobile phase: consists of mobile phase A and mobile phase B.

[0150] Mobile phase A was 0.1% trifluoroacetic acid in water,

[0151] Mobile phase B is 0.1% trifluoroacetic acid methanol-tetrahydrofuran (1:1)

[0152] Elution gradient:

[0153]

[0154] Column temperature: 30°C;

[0155] Flow rate: 1.0ml / min;

[0156] Detection wavelength: 272nm.

[0157] Assay:

[0158] Test solution:

[0159] Accurately weigh about 100 mg of intermediate C, put it in a 50 ml measuring bottle, add 50% methanol water to dissolve and dilute to the mark, and use it as the test solution to obtain the concentration ru of the test solution;

[0160] Control solution:

[0161] Accurately weigh about 10 mg of impurity 1, impurity 2, starting material, and intermediate C reference substance respectively, put them in a 10ml mea...

Embodiment 2

[0164] Embodiment 2 Intermediate C Related Substance Detection

[0165] Chromatographic conditions:

[0166] Filler with octadecylsilane bonded silica gel;

[0167] Mobile phase: consists of mobile phase A and mobile phase B.

[0168] Mobile phase A was 0.1% trifluoroacetic acid in water,

[0169] Mobile phase B is 0.1% trifluoroacetic acid methanol-tetrahydrofuran (1:1)

[0170] Elution gradient:

[0171]

[0172] Column temperature: 30°C;

[0173] Flow rate: 0.9ml / min;

[0174] Detection wavelength: 272nm.

[0175] Assay:

[0176] Test solution:

[0177] Accurately weigh about 100 mg of intermediate C, put it in a 50 ml measuring bottle, add 50% methanol water to dissolve and dilute to the mark, and use it as the test solution to obtain the concentration ru of the test solution;

[0178] Control solution:

[0179] Accurately weigh about 10 mg of impurity 1, impurity 2, starting material, and intermediate C reference substance respectively, put them in a 10ml mea...

Embodiment 3

[0182] Embodiment 3 Intermediate C Related Substance Detection

[0183] Chromatographic conditions:

[0184] Filler with octadecylsilane bonded silica gel;

[0185] Mobile phase: consists of mobile phase A and mobile phase B.

[0186] Mobile phase A was 0.1% trifluoroacetic acid in water,

[0187] Mobile phase B is 0.1% trifluoroacetic acid methanol-tetrahydrofuran (1:1)

[0188] Elution gradient:

[0189]

[0190] Column temperature: 30°C;

[0191] Flow rate: 1.1ml / min;

[0192] Detection wavelength: 272nm.

[0193] Assay:

[0194] Test solution:

[0195] Accurately weigh about 100 mg of intermediate C, put it in a 50 ml measuring bottle, add 50% methanol water to dissolve and dilute to the mark, and use it as the test solution to obtain the concentration ru of the test solution;

[0196] Control solution:

[0197] Accurately weigh about 10 mg of impurity 1, impurity 2, starting material, and intermediate C reference substance respectively, put them in a 10ml mea...

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Abstract

The invention discloses a method for detecting related substances of sarpogrelate hydrochloride intermediate C. The method is simple, and the precision, accuracy, reproducibility and durability are good. The method can be used for quality control of the related substances of the sarpogrelate hydrochloride raw material intermediate C, namely 1-(dimethylamino)-3-[2-[2-(3-methoxyphenyl)ethyl]phenoxy]-2-propyl-alcohol hydrochloride.

Description

technical field [0001] The invention belongs to the field of drug detection, and in particular relates to a method for detecting related substances containing sargrelate hydrochloride intermediate C. Background technique [0002] Sarpogrelate hydrochloride is a 5-hydroxytryptamine (5-HT2) receptor blocker that can specifically bind to 5-HT2 receptors. 5-hydroxytryptamine (5-HT) was first proposed as a vasoactive substance in 1955. 5-HT exists widely in animals, especially in the cardiovascular system. Except for a small part that is re-uptaked and stored in platelets, almost all 5-HT is inactivated by endothelial cells in the liver and lungs. Sagrelate hydrochloride can specifically bind to 5-HT2 receptors, showing a special antagonistic effect on receptors on platelets and vascular smooth muscle. Therefore, it exhibits anti-platelet effect and inhibits vasoconstriction, and exerts a series of biological effects. Sagrelate hydrochloride is an antithrombotic drug, mainly u...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 韩冬贺英张娇娇许磊郭嘉林孔凯刘登科董凯
Owner TIANJIN CHASE SUN PHARM CO LTD
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