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A method for detecting dronedarone hydrochloride

A hydrochloride and high-performance liquid chromatography technology, which is applied in the field of drug monitoring, can solve problems such as unfavorable production and treatment of diseases, low accuracy of results, and impact on the quality of dronedarone hydrochloride.

Active Publication Date: 2016-03-23
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In these synthetic methods, the depropylated impurities will be brought into the raw materials, and the impurity 2-methyl-3-[4-(3-di-n-butylaminopropoxy)benzoyl will be produced as the subsequent reaction proceeds. ]-5-Methanesulfonamidobenzofuran hydrochloride; the demethylated impurities are brought into the raw materials, and the impurity 2-n-propyl-3-[4-(3-di-n-butyl Aminopropoxy)benzoyl]-5-methanesulfonamidobenzofuran hydrochloride; the mesylation reaction in the synthesis process will produce the side reaction product 2-n-butyl-3-[4-( 3-Di-n-butylaminopropoxy)benzoyl]-5-dimethylsulfonamidobenzofuran hydrochloride; in the process of synthesis, the intermediate 5-amino-3-[4- (3-Di-n-butylaminopropoxy)benzoyl]-2-n-butylbenzofuran dioxalate, in addition to degradation products and unknown impurities, the presence of these substances will affect droneida hydrochloride The quality of dronedarone hydrochloride is detected in the prior art, and the accuracy of the results obtained is not high, which is not conducive to production and disease treatment

Method used

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  • A method for detecting dronedarone hydrochloride
  • A method for detecting dronedarone hydrochloride
  • A method for detecting dronedarone hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～4

[0165] According to the records of Appendix III of the Chinese Pharmacopoeia 2010 edition, the identification of obvious chlorides was carried out. Accurately weigh 10 mg of dronedarone hydrochloride samples purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd. and dronedarone hydrochloride tablets purchased from Sanofi-Aventis with batch numbers 110401, 110402 and 110403 , add 15 mL each of ethanol and water and 5 mL of ammonia test solution, shake, stand still, and filter, and operate the obtained filtrate according to the method in the Pharmacopoeia to identify the apparent chloride.

[0166] The results showed that the test results of the samples in Examples 1-4 were all positive, and negative without interference.

Embodiment 5～9

[0168] Accurately weighed 25mg samples of dronedarone hydrochloride purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd. and dronedarone hydrochloride purchased from Sanofi-Aventis (Sanofi-Aventis) with batch numbers 110401, 110402 and 110403 Tablets and blank excipients, put them in 50mL measuring bottles, add absolute ethanol to dissolve and dilute to the mark, shake well, let it stand, filter; accurately measure 1mL of the filtrate, put it in a 50mL volume In the bottle, add molar concentration to it and be 0.1mol / L hydrochloric acid solution to dissolve and dilute to every 1mL containing the solution of dronedarone hydrochloride 10 μ g, according to the ultraviolet-visible spectrophotometry method that Chinese Pharmacopoeia 2010 edition two appendix IVA record To measure.

[0169] The result is as Figure 1~5 as shown, Figure 1~4 Respectively, the ultraviolet spectrograms of the dronedarone hydrochloride tablets obtained in Examples 5 to 8 of the present invention, ...

Embodiment 10～12

[0174] Add the reference substance of dronedarone hydrochloride into the mobile phase, perform ultrasonic dissolution, and prepare a solution containing about 1 mg of dronedarone hydrochloride per 1 mL to obtain the solution to be tested. The mobile phase is a mixed solution of methanol-acetonitrile-phosphate buffer solution, wherein the phosphate buffer solution is prepared as follows: get 0.136g of potassium dihydrogen phosphate, add 200mL of water to dissolve, adjust the pH value with sodium hydroxide test solution To 7.5, add water to 1000mL, shake well, the volume ratio of methanol-acetonitrile-phosphate buffer solution in the mobile phase is 32:50:18.

[0175] Weigh about 30mg of the blank excipient, put it in a 50mL measuring bottle, add the above-mentioned mobile phase to dissolve and dilute to the mark, shake well to obtain the blank solution.

[0176] Precisely measure 10 μL each of the above mobile phase, blank solution and solution to be tested and inject it into t...

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Abstract

The invention provides a method for detecting N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)Methanesulfonamide hydrochloride (dronedarone hydrochloride). N-(2-Butyl-3-(4-(3-(dibutylaMino)propoxy)benzoyl)benzofuran-5-yl)MethanesulfonaMide hydrochloride is detected by employing high performance liquid chromatography. Under the high performance liquid chromatography conditions provided by the invention, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)Methanesulfonamide hydrochloride can be relatively well isolated from concomitant impurities, and all impurities can be relatively well separated. The provided method has relatively high sensitivity, and therefore the provided method is capable of relatively accurately determining N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)Methanesulfonamide hydrochloride.

Description

technical field [0001] The invention relates to the technical field of drug monitoring, in particular to a method for detecting N-(2-butyl-3-(4-(3-dibutylaminopropoxy)benzoyl)benzofuran-5-yl)methanol Sulfonamide hydrochloride method. Background technique [0002] Dronedaronehydrochloride, which is N-(2-butyl-3-(4-(3-dibutylaminopropoxy)benzoyl)benzofuran-5-yl)methanesulfonamide The common name for 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. [0003] Atrial fibrillation is a potentially life-threatening disease. Due to the aging population, the global inciden...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N21/33
Inventor 萧伟仲艳潘红娟傅小勤李家春王振中毕宇安章晨峰徐丰果于丹
Owner JIANGSU KANION PHARMA CO LTD
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