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Content measuring method of dronedarone hydrochloride

A technology for dronedarone hydrochloride and its determination method, which is applied in the field of detection of drug content, can solve the problems of dronedarone hydrochloride quality impact, unfavorable production and disease treatment, and low accuracy of results, so as to ensure quality and small error , to ensure the effect of clinical effect

Inactive Publication Date: 2018-04-24
朱隆娅
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Problems solved by technology

In the existing synthesis process of dronedarone hydrochloride, there are many degradation products and unknown impurities. The existence of these substances will affect the quality of dronedarone hydrochloride. The detection of dronedarone hydrochloride in the technology is accurate. The degree is not high, which is not conducive to production and treatment of diseases

Method used

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Embodiment Construction

[0009] 1. Instruments and conditions

[0010] Shimadzu LC-10ATVP pump, Shimadzu SPD-10AVP ultraviolet-visible multi-wavelength detector, RHEODYNE 7725i sampler and TL9900 chromatographic data workstation; the chromatographic conditions are as follows:

[0011] The chromatographic column is an octadecylsilane bonded silica gel column; tetrahydrofuran-0.5% phosphoric acid solution is used as the mobile phase (the volume ratio of tetrahydrofuran to 0.05% phosphoric acid solution is 48:52); the column temperature is 35°C; the detection wavelength is 245nm; It is 1.0mL / min; the injection volume is 10μL.

[0012] 2. Test reagents and drugs: Dronedarone hydrochloride original drug, dronedarone hydrochloride reference substance, reagents tetrahydrofuran and phosphoric acid are analytically pure.

[0013] 3. Detection method:

[0014] 3.1 Preparation of the test solution: Accurately weigh 1 g of the dried dronedarone hydrochloride sample, put it in a 50ml volumetric flask, set to vol...

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Abstract

The invention relates to a content measuring method of dronedarone hydrochloride. Chromatographic conditions of the method include that a packed column is octadecyl silane bonded silica gel, a mobilephase is tetrahydrofuran-0,05% phosphoric acid solution, flow rate of the mobile phase is 1.0ml / min, column temperature is 35 DEG C, detection wavelength is 245nm, and sample size is 10ul. The methodis accurate and reliable in dronedarone hydrochloride content measuring result, simple, convenient and scientific, meets requirements of Chinese pharmacopoeia and is good in detection result.

Description

technical field [0001] The invention belongs to a method for detecting drug content, in particular to a method for determining the content of dronedarone hydrochloride. Background technique [0002] Dronedarone hydrochloride, which is N-(2-butyl-3-(4-(3-dibutylaminopropoxy)benzoyl)benzofuran-5-yl)methanesulfonate The common name for amide hydrochloride is an antiarrhythmic drug. The drug has similar electrophysiological effects to amiodarone, but it does not contain iodine, so it will not cause adverse reactions related to iodine. It is an alternative and newer drug for amiodarone. This product is suitable for heart rate control, maintenance of sinus rhythm and slowing of ventricular rhythm in patients with atrial fibrillation and atrial flutter. It is mainly used clinically to treat arrhythmia. In the existing synthesis process of dronedarone hydrochloride, there are many degradation products and unknown impurities. The existence of these substances will affect the qualit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/74
CPCG01N30/02G01N30/74
Inventor 朱隆娅
Owner 朱隆娅
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