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Dabigatran etexilate mesylate or its preparation related substances or/and detection method

A technology for dabigatran etexilate mesylate and related substances, which is applied in the field of detection of dabigatran etexilate mesylate or its preparation related substances or/and contents, can solve problems such as inability to detect impurities of related substances, and achieves the The effect of good chromatographic peak resolution

Active Publication Date: 2022-05-20
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem mainly solved by the present invention is that the existing detection method of dabigatran etexilate mesylate or its preparation related substances can only detect the degraded impurities of capsules, and many related substances impurities cannot be detected

Method used

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  • Dabigatran etexilate mesylate or its preparation related substances or/and detection method
  • Dabigatran etexilate mesylate or its preparation related substances or/and detection method
  • Dabigatran etexilate mesylate or its preparation related substances or/and detection method

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Embodiment 1

[0043] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler chromatographic column (recommended Phenomenex Gemini C18, 4.6×250mm, 5μm), with 0.2% ammonium acetate solution (glacial acetic acid to adjust the pH value to 4.3) The mobile phase is A, acetonitrile is used as the mobile phase B, and the gradient elution is carried out in the following table; the column temperature is 35°C, the flow rate is 1.0ml / min, and the detection wavelengths are 242nm, 310nm, and 340nm.

[0044]

[0045] Take the reference substance of impurity 6, weigh it accurately, dissolve it with diluent 1 [acetonitrile-ethanol-water (12:3:10)] and dilute it with diluent 2 [mobile phase A-mobile phase B (85:15)]. The solution containing about 0.3mg in each 1ml is used as the reference substance solution (1); Impurity 02, Impurity 5, Impurity 7, Impurity 9, Impurity 1, Impurity 2, Impurity 4, Impurity 8, Impurity 10, Impurity 11. The reference substances ...

Embodiment 2

[0052] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler chromatographic column (recommended Phenomenex Gemini C18, 4.6×250mm, 5μm), with 0.3% ammonium acetate solution (glacial acetic acid to adjust the pH value to 4.3) The mobile phase is A, acetonitrile is used as the mobile phase B, and the gradient elution is carried out in the following table; the column temperature is 35°C, the flow rate is 1.0ml / min, and the detection wavelengths are 242nm, 310nm, and 340nm.

[0053]

[0054]

[0055] Take the reference substance of impurity 6, weigh it accurately, dissolve it with diluent 1 [acetonitrile-ethanol-water (12:3:10)] and dilute it with diluent 2 [mobile phase A-mobile phase B (85:15)]. The solution containing about 0.3mg in each 1ml is used as the reference substance solution (1); Impurity 02, Impurity 5, Impurity 7, Impurity 9, Impurity 1, Impurity 2, Impurity 4, Impurity 8, Impurity 10, Impurity 11. The reference...

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Abstract

A kind of detection method of dabigatran etexilate mesylate or its preparation related substance or / and content, described detection method adopts high performance liquid chromatography to detect, and detection condition comprises: chromatographic column: reverse phase silica gel chromatographic column, detection wavelength : 210~400nm, mobile phase: mobile phase A: aqueous phase containing buffer, pH is 4.25~4.40; mobile phase B: mainly includes methanol or acetonitrile; mobile phase is eluted by gradient elution. The detection method of the invention can separate the chromatographic peaks of the dabigatran etexilate mesylate and related substances in its preparation, and has good chromatographic peak separation.

Description

technical field [0001] The invention relates to the field of detection methods for related substances, in particular to a method for detecting related substances or / and content of dabigatran etexilate mesylate or its preparations. Background technique [0002] Dabigatran etexilate mesylate was developed by Boehringer Ingelheim, Germany, and was first approved by the US Food and Drug Administration in 2010 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It is a direct thrombin inhibitor , the prodrug of dabigatran, belongs to non-peptide thrombin inhibitors, the latter is released in the body after oral administration, and binds to the fibrin-specific site of thrombin to prevent fibrinogen from cracking into fibrin, thus preventing Breaking the final step of the coagulation cascade network and thrombus formation, the drug is launched, which is a major progress in the field of anticoagulation therapy and the prevention of p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/74
CPCG01N30/02G01N30/34G01N30/74
Inventor 陈翠翠葛志乐罗鸣赵同华周巍何威轩李英富苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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