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Method for detecting genotoxic impurities in bepotastine besilate

A technology of bepotastine besylate and a detection method, applied in the field of drug analysis, can solve problems such as poor sensitivity and unstable detection of genotoxic impurities, and achieve the effects of high sensitivity, reduction of abnormal chromatographic peaks, and good practicability

Inactive Publication Date: 2020-06-19
澳美制药(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a detection method for genotoxic impurities in bepotastine bepotastine, aiming to solve the technical problem of poor sensitivity caused by the unstable detection of genotoxic impurities in bepotastine besilate

Method used

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  • Method for detecting genotoxic impurities in bepotastine besilate
  • Method for detecting genotoxic impurities in bepotastine besilate
  • Method for detecting genotoxic impurities in bepotastine besilate

Examples

Experimental program
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Effect test

Embodiment 1

[0045] The detection method of genotoxic impurity in bepotastine besilate comprises the steps:

[0046] (1) Preparation of the test solution: take an appropriate amount of this product powder (approximately equivalent to 40 mg bepotastine besilate), weigh it accurately, put it in a 10ml measuring bottle, add an appropriate amount of acetonitrile, dissolve it by ultrasonication for 2 minutes, and cool to room temperature , dilute to the mark with acetonitrile, shake well, filter, and take the continued filtrate as the test solution.

[0047] (2) Preparation of reference substance solution: take another appropriate amount of reference substances of methyl benzenesulfonate, ethyl benzenesulfonate and isopropyl benzenesulfonate, weigh them accurately, and quantitatively dilute with acetonitrile to make about 4.0 μg in each 1ml solution, as the reference solution.

[0048] (3) High-performance liquid chromatography detection: Precisely measure 20 μl each of the test solution and t...

Embodiment 2

[0085] Investigate the influence of solvent effect on impurity peak shape under different chromatographic columns:

[0086] Diluent: Acetonitrile

[0087] Concentration of isopropyl benzenesulfonate: 1.0μg / ml

[0088] Column:

[0089] Waters Symmetry C18 4.6*250mm, 5μm (carbon load is 19% and specific surface area is 335m2 / g);

[0090] Waters Spherisorb ODS2 C18 4.6*250mm, 5μm (carbon load is 11.5% and specific surface area is 200m 2 / g);

[0091] GL sciences Inertsil ODS3 C18 4.6*250mm, 5μm (carbon loading is 15% and specific surface area is 450m 2 / g);

[0092] from the chromatogram image 3 It shows that the use of GL sciences Inertsil ODS3 C18 can eliminate the abnormal peak shape caused by the solvent effect and make the peak shape of genotoxic impurities meet the requirements.

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting genotoxic impurities in bepotastine besilate. According to the detection method, high performance liquid chromatography is adopted for determination; the high performance liquid chromatography is reversed-phase liquid chromatography; and chromatographic conditions include that a chromatographic column with the carbon loading capacity smaller than or equal to 15% and the specific surface area larger than or equal to 450 m < 2 > / g is adopted, and acetonitrile serves as a solvent of a to-be-detected sample solution. The detection method has a good separation effect on genotoxic impurities in bepotastine besilate, and is high in sensitivity, good in stability and good inpracticability.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a detection method for genotoxic impurities in bepotastine besilate. Background technique [0002] Stine drugs are potent, long-acting, and highly selective histamine H1 receptor blockers, and have no inhibitory effect on cholinergic receptors in the central nervous system, and have no sedative and drowsy effects. First-line non-hormonal drugs for allergic rhinitis. Bepotastine bepotastine is the benzenesulfonate of bepotastine, which is a white to off-white crystalline powder. Due to the use of alcohol solvents in its synthesis process, there may be genotoxic impurities of bepotastine Therefore, it is of great significance to control the content of benzenesulfonate genotoxic impurities. [0003] In the existing patent CN107782832A, the HPLC method and the gradient elution method can be used to effectively separate potential genotoxic impurities in bepotastine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/32G01N30/30G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324
Inventor 曹丽丽孙娟欧明鸿
Owner 澳美制药(苏州)有限公司
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