Analysis method of related substances in Ebastine

A technology related to substances and analysis methods, applied in the field of drug analysis, can solve the problems of long analysis time period, complicated mobile phase configuration, inconvenient measurement, etc., and achieve reliable measurement results
CN102095808BActive Publication Date: 2014-04-02CHONGQING HUAPONT PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
CHONGQING HUAPONT PHARMA
Publication Date
2014-04-02

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Abstract

The invention relates to an analysis method of related substances in Ebastine. Using reversed-phase high performance liquid chromatography selecting octadecylsilane bonded silica as a packing material, selecting a proper organic phase and a buffer solution as the mobile phase, and adopting gradient elution, the method can effectively separate the related substances in the pharmaceutical material Ebastine. The method is quick, simple, effective and reliable.
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Description

Technical field:

[0001] The invention relates to a drug analysis method, in particular to a method for determining related substances of ebastine by high performance liquid chromatography. Background technique:

[0002] The so-called "related substances" in drug analysis refer to substances that are not the main components in a specific drug, but are related to the ingredients. Because a drug has to go through a relatively complicated and lengthy process from the synthesis of raw materials to the preparation of related preparations, storage, transportation, and use, during this period, each process may produce related substances, such as production. Starting materials, reagents, intermediates, by-products and isomers may be brought in; during storage and transportation, special impurities such as degradation products, polymers or crystal transformations may be produced. In order to ensure the safety and effectiveness of the drug, the actual production situation must also be...

Claims

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