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Method for detecting organic-solvent residues in dabigatran etexilate

A technology of dabigatran etexilate and organic solvents, which is applied in the field of drug analysis and detection, can solve problems such as hazards, and achieve the effects of good repeatability, high precision, and high sensitivity

Inactive Publication Date: 2015-06-03
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Abstract
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Problems solved by technology

If the concentration of residual organic solvents contained in the medicine is higher than the safe value, it will cause harm to the human body after taking it

Method used

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  • Method for detecting organic-solvent residues in dabigatran etexilate
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  • Method for detecting organic-solvent residues in dabigatran etexilate

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Embodiment

[0033] 1. Instruments and reagents

[0034] Instrument: Agilent6890 gas chromatograph, detector FID; Agilent chromatography workstation; Reagents: All reagents used are chromatographically pure.

[0035] 2. Chromatographic conditions

[0036] Chromatographic column: Agilent DB-1301 (30m×0.32mm×0.25μm); column temperature: programmed temperature, the initial temperature was 40°C, maintained for 6min, and then the temperature was increased to 180°C at a rate of 50°C / min, maintained for 10min; Sample port temperature: 200℃; Detection temperature: 250℃; Carrier gas: N 2 , flow rate 2ml / min; injection method: headspace injection method; equilibration time: 30min; equilibration temperature: 90 ℃.

[0037] 3. Solution preparation

[0038] Accurately weigh 500 mg, 500 mg, 500 mg, 72 mg of ethanol, acetone, ethyl acetate, and tetrahydrofuran, add N,N-dimethylformamide, and dissolve them in a 100-ml volumetric flask. The concentration is 5 mg of ethanol and acetone per 1 ml. 5mg, et...

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Abstract

The invention relates to a method for detecting organic-solvent residues in dabigatran etexilate, and particularly relates to a method for simultaneously detecting residues of alcohol, acetone, ethyl acetate and tetrahydrofuran in dabigatran etexilate by gas chromatography. An external standard method is adopted for simultaneously detecting the amount of the residues of four types of organic solvents in the dabigatran etexilate, and the chromatographic conditions are as follows: a chromatographic column is in the type of Agilent DB-1301 (30m*0.32mm*0.25microns), the column temperature is increased by programming, the initial temperature is 40 DEG C, the maintaining time is 6 minutes, then the temperature is increased to be 180 DEG C at a speed of 50 DEG C / min and is maintained for 10 minutes, the temperature of a sample inlet is 200 DEG C, the detection temperature is 250 DEG C, carrier gas is N2, the flow is 2ml / min, a headspace sampling method is adopted, the balance time is 30 minutes and the balance temperature is 90 DEG C. The method is high in sensitivity, good in repeatability and high in accuracy, and is suitable for detecting the organic-solvent residues in the dabigatran etexilate.

Description

technical field [0001] The invention relates to a method for detecting organic solvent residues in dabigatran etexilate, in particular to a method for simultaneously detecting ethanol, acetone, ethyl acetate and tetrahydrofuran residues in dabigatran etexilate by gas chromatography, belonging to the field of drug analysis and detection . Background technique [0002] Dabigatran etexilate, trade name Pradaxa, is a new type of anticoagulant drug with various characteristics developed by Boehringer Ingelheim, Germany. Dabigatran etexilate is a prodrug of dabigatran , which is converted in vivo to active dabigatran, which exerts an anticoagulant effect by directly inhibiting thrombin. Dabigatran etexilate can be used for DVT prophylaxis after knee and hip replacement, DVT therapy, atrial fibrillation, secondary prevention of coronary events, with fixed-dose administration and without laboratory monitoring. item advantage. [0003] Residual solvents in pharmaceuticals refer to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 冯光玲丁文娟冯爱国冀东王迎春
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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