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Dabigatran etexilate mesylate content detection method

A technology of dabigatran etexilate mesylate and a detection method, applied in the field of medicine, can solve the problem of no dabigatran etexilate mesylate, etc., and achieve the effects of improving product quality and optimizing process

Active Publication Date: 2016-05-11
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no effective detection method for dabigatran etexilate mesylate. In order to facilitate the synthesis personnel to analyze the yield, this analysis method is specially studied, which can simply, quickly and accurately determine its content

Method used

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  • Dabigatran etexilate mesylate content detection method
  • Dabigatran etexilate mesylate content detection method
  • Dabigatran etexilate mesylate content detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Accurately weigh 10mg of dabigatran etexilate mesylate standard substance and dissolve it in a 10ml volumetric flask, dissolve it with methanol and dilute to the mark, shake well, and make a standard solution with a concentration of 1mg / ml.

[0018] Accurately prepare yohimbine standard solution according to the above method, filter it through a 0.2 μm microporous filter head and inject it into a liquid chromatograph, according to the method determined in the present invention. The five yohimbine standard solutions with different concentrations are 0.8mg / ml, 0.9mg / ml, 1.1mg / ml and 1.2mg / ml respectively. Take the peak area (Y) as the ordinate, and the sample concentration (X) as the abscissa to carry out linear regression, get r=0.999, the linear relationship is very good, see image 3 .

[0019] Among them, chromatographic column: phenomenonexGeminiC18 (150×4.6mm, 5μm); mobile phase: A: 0.01mol / L ammonium acetate aqueous solution, acetic acid to adjust the pH to 6.5; B...

Embodiment 2

[0028] Reference substance solution: Accurately weigh an appropriate amount of dabigatran etexilate mesylate reference substance (purchased from sigma), dissolve it with methanol, and constant volume to make a solution containing 1 mg of dabigatran etexilate mesylate per 1 ml;

[0029] Need testing solution: Accurately take dabigatran etexilate mesylate test sample appropriate amount, dissolve with methanol, constant volume, make the solution that contains test sample 1mg in every 1ml approximately. (The test product is the product of the unit's synthesis room)

[0030] Take 10 μl each of the control solution and the test solution, inject them into the chromatograph, record the chromatogram, and calculate the peak area according to the external standard method to obtain the labeled amount of dabigatran etexilate mesylate.

[0031] Use the optimized chromatographic conditions in Example 1 to check, wherein, figure 1 Be the chromatogram of dabigatran etexilate mesylate test sam...

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Abstract

The present invention relates to a dabigatran etexilate mesylate content detection method, which concretely comprises that: 1) the chromatographic conditions of HPLC for determining the dabigatran etexilate mesylate comprise that the chromatographic column is phenomenex GeminiC18 (150*4.6 mm, 5 um), the mobile phase A is a 0.01 mol / L ammonium acetate aqueous solution, the pH value is adjusted to 6.5 with acetic acid, the mobile phase B is methanol, isocratic elution is performed according to a ratio of A to B of 35:65, the flow rate is 1 ml / min, the column temperature is 30 DEG C, the detection length of the DAD detector is 272 nm, and the injection volume is 10 [mu]l. According to the present invention, through the effective high performance liquid chromatography, the dabigatran etexilate mesylate content is detected, the dabigatran etexilate mesylate content is precisely detected, the process is easily optimized, and the product quality is easily improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically, mainly relates to a detection method for the content of dabigatran etexilate mesylate. Background technique [0002] Dabigatran etexilate (Pradaxa) is an oral direct thrombin inhibitor developed and produced by Boehringer Ingelheim in Germany. It is the prodrug of Dabigatran (Dabigatran). Based on the product generated by sulfonation reaction. It was first launched in Germany and the UK in April 2008. Dabigatran etexilate has direct anticoagulant activity, has little effect with other drugs, and can be directly taken orally without blood coagulation tests or changes in dietary habits. It is a recommended drug for stroke prevention. In 2008, it was approved by the European Union for the prevention of venous thrombosis after total hip or total knee replacement. In 2010, it was approved by the FDA for the prevention of thrombosis and stroke in patients with non-valvular atrial f...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 姜明赵迎春冯新光
Owner HUAREN PHARMACEUTICAL CO LTD
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