Method for detecting impurities in formoterol fumarate or related preparations thereof

A technology of formoterol fumarate and impurities, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as poor reproducibility of test results, short service life of chromatographic columns, lack of diastereoisomers, etc. Achieve excellent reproducibility, low price, and make up for the effect of diastereomer impurity content
CN110376313AActive Publication Date: 2019-10-25GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD
Publication Date
2019-10-25

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Abstract

The present invention provides a method for detecting impurities in formoterol fumarate or related preparations thereof. The method comprises a step of detecting diastereoisomer impurities (impuritiesI) in the formoterol fumarate or related preparations by using a high performance liquid chromatography method, wherein an eluent used in the high performance liquid chromatography is a system consisting of a liquid A and a liquid B, the liquid A is an ion pair reagent buffer, the liquid B is acetonitrile, and the elution mode is isocratic elution. The method of the invention has the advantages of good tolerance, long service life, the good reproducibility of a detection result, and multiple types of optional columns, and the reduction of the application cost. A measurement result obtained bythe method of the invention is accurate, and the method can be simultaneously applied to the detection of the content of diastereoisomer impurities in a formoterol fumarate crude drug and related preparations.
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Description

technical field

[0001] The invention relates to the technical field of drug detection, in particular to a method for detecting impurities in formoterol fumarate or its related preparations. Background technique

[0002] Formoterol Fumarate is a β2-adrenoceptor agonist developed by Yamanouchi Pharmaceutical Co., Ltd., Japan, for the treatment of bronchial asthma, acute bronchitis or asthmatic bronchitis and other airway obstructive pulmonary diseases , chemical name: (±)-N-[2-hydroxy-5-[(1RS)-hydroxy-2[[(1RS)-2-(4-methoxybenzyl)-1-methylethyl] Amino] ethyl] phenyl] formamide fumarate dihydrate is a pharmaceutically acceptable salt of Formoterol (Formoterol), and its structure is as shown in formula (1):

[0003]

[0004] At present, the Chinese guidelines for asthma prevention, the American Thoracic Society (ATS) and the European Respiratory Society (ERS) have listed formoterol fumarate as the preferred long-acting β2 receptor agonist as a bronchodilator for controlling a...

Claims

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