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A method for detecting related substances in ebastine

A detection method and related substance technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of ineffective detection and separation of impurities in ebastine raw material drugs, and achieve simple operation, saving detection time, and detection and analysis. short cycle effect

Active Publication Date: 2022-05-17
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Our technical plan is based on the improvement of the existing technology that cannot effectively detect and separate impurities in ebastine raw materials, and explores and optimizes related plans.

Method used

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  • A method for detecting related substances in ebastine
  • A method for detecting related substances in ebastine
  • A method for detecting related substances in ebastine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] A method for detecting related substances in ebastine, comprising the following steps:

[0058](1) Preparation of the test solution: take an appropriate amount of ebastine raw material, dilute it with a solvent to a solution containing about 2.5mg per 1ml, and use it as the test solution;

[0059] (2) Preparation of control solution: measure the test solution, quantitatively dilute it with diluent to make a solution containing 2.5 μg per 1 ml, as the control solution;

[0060] (3) Preparation of mobile phase: Measure 800ml of water, add 12ml of phosphoric acid, 12ml of diethylamine, adjust the pH to 5.7 with diethylamine, then dilute to 1000ml with water to prepare mobile phase A, according to the volume ratio of 42:38 Take acetonitrile solution and methanol solution to configure mobile phase B;

[0061] (4) Determination: Use C18 reversed-phase chromatographic column, use diethylamine to adjust the pH value of 5.7 phosphate buffer solution and methanol as mobile phase...

Embodiment 2

[0071] A method for detecting related substances in ebastine, comprising the following steps:

[0072] (1) Preparation of the test solution: take an appropriate amount of ebastine raw material, dilute it with a solvent to a solution containing about 2.5mg per 1ml, and use it as the test solution;

[0073] (2) Preparation of control solution: measure the test solution, quantitatively dilute it with diluent to make a solution containing 2.5 μg per 1 ml, as the control solution;

[0074] (3) Preparation of mobile phase: Measure 800ml of water, add 12ml of phosphoric acid, 12ml of diethylamine, adjust the pH to 5.7 with diethylamine, then dilute to 1000ml with water to prepare mobile phase A, according to the volume ratio of 42:38 Take acetonitrile solution and methanol solution to configure mobile phase B;

[0075] (4) Determination: Use C18 reversed-phase chromatographic column, use diethylamine to adjust the pH value of 5.7 phosphate buffer solution and methanol as mobile phas...

Embodiment 3

[0083] A method for detecting related substances in ebastine, comprising the following steps:

[0084] (1) Preparation of the test solution: take an appropriate amount of ebastine raw material, dilute it with a solvent to a solution containing about 2.5mg per 1ml, and use it as the test solution;

[0085] (2) Preparation of control solution: measure the test solution, quantitatively dilute it with diluent to make a solution containing 2.5 μg per 1 ml, as the control solution;

[0086] (3) Preparation of mobile phase: Measure 800ml of water, add 12ml of phosphoric acid, 12ml of diethylamine, adjust the pH to 5.7 with diethylamine, then dilute to 1000ml with water to prepare mobile phase A, according to the volume ratio of 42:38 Take acetonitrile solution and methanol solution to configure mobile phase B;

[0087] (4) Determination: Use C18 reversed-phase chromatographic column, use diethylamine to adjust the pH value of 5.7 phosphate buffer solution and methanol as mobile phas...

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Abstract

The application discloses a method for detecting related substances in ebastine, which uses high-performance liquid chromatography and performs gradient elution. By using the detection method, each component in the ebastine bulk drug can be effectively detected and separated, and the analysis time is suitable and the operation is simple and convenient.

Description

technical field [0001] The invention relates to the field of pharmaceutical chemical analysis, in particular to a method for detecting related substances in ebastine. Background technique [0002] Ebastine, the chemical name is 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)-1-piperidinyl ]-1-butanone, whose molecular formula is C 32 h 39 NO 2 , the molecular weight is 469.67, and the structural formula is as follows: [0003] . [0004] Ebastine, also known as Kaisiting; Aibading; Secoding, is usually a non-hygroscopic, white crystalline powder. Ebastine is a histamine H1 receptor blocker, its antihistamine activity is competitive at low concentrations and non-competitive at high concentrations. It is clinically used for allergic diseases, including allergic rhinitis in children, perennial rhinitis in adults, seasonal rhinitis, hay fever and chronic urticaria. [0005] Ebastine is highly selective for H1 receptors and has no central inhibitory effect. Compa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 陈卉谭稳肖稳定
Owner HUNAN JIUDIAN PHARMA
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