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Rupatadine fumarate tablet related substance control method

A technology for rupatadine fumarate and related substances, which is applied in the field of drug analysis and can solve problems such as shortening the service life of a chromatographic column and damage to the chromatographic column.

Inactive Publication Date: 2018-09-07
扬子江药业集团江苏紫龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of the currently reported detection methods for rupatadine fumarate related substances use ion-pairing reagents, which can irreversibly damage the chromatographic column and greatly shorten the service life of the chromatographic column

Method used

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  • Rupatadine fumarate tablet related substance control method
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  • Rupatadine fumarate tablet related substance control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Instrument and Chromatographic Conditions

[0025] Agilent 1260 high-performance liquid chromatography; the chromatographic column is a C18 chromatographic column, 150mm×4.6mm×5μm, and the column temperature is 30°C;

[0026] Using 20 mmol phosphate aqueous solution [adding 0.1% (v / v) triethylamine, adjusting the pH to 5.0 with dilute phosphoric acid] as mobile phase A, using acetonitrile as mobile phase B, the gradient elution procedure is as follows:

[0027]

[0028] The mobile phase flow rate is 1.2ml / min;

[0029] Using a UV detector, the detection wavelength is set to 210nm;

[0030] Experimental procedure

[0031] Take an appropriate amount of rupatadine fumarate reference substance, impurities A, B, C, and F, dissolve and dilute with a diluent to make a mixed solution containing 200 μg of each impurity and rupatadine per 1 ml, as a linear test stock solution. Precisely measure 1.0ml, 1.0ml, 1.0ml, 3.0ml, 2ml of linear test stock solution, put them in 50ml...

Embodiment 2

[0035] Instrument and Chromatographic Conditions

[0036] Agilent 1260 high-performance liquid chromatography; the chromatographic column is a C18 chromatographic column, 150mm×4.6mm×5μm, and the column temperature is 30°C;

[0037] Using 20 mmol phosphate aqueous solution [adding 0.1% (v / v) triethylamine, adjusting the pH to 5.0 with dilute phosphoric acid] as mobile phase A, using acetonitrile as mobile phase B, the gradient elution procedure is as follows:

[0038]

[0039] The mobile phase flow rate is 1.2ml / min;

[0040] Using a UV detector, the detection wavelength is set to 210nm;

[0041] Experimental procedure

[0042] Take an appropriate amount of fine powder of this product (approximately equivalent to rupatadine 10mg), put it in a 20ml measuring bottle, add an appropriate amount of diluent (mobile phase A-acetonitrile=80:20, V:V), dissolve it by ultrasonic, and dilute with diluent to the mark, shake well, filter, and take the filtrate as the test solution; ac...

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Abstract

The invention discloses a high performance liquid chromatography determination method for rupatadine fumarate tablet related substances, wherein impurities are quantified by using a calibration factorcontained main component self-contrasted method. According to the present invention, the operation of the method is simple and easy to perform; and the test results prove that the selected chromatographic conditions can well separate the main component and the related substances so as to well control the related substances of the rupatadine fumarate tablet.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for separating and detecting related substances in rupatadine fumarate tablets by high performance liquid chromatography. Background technique [0002] Allergic rhinitis, also known as allergic rhinitis, is a common and frequently-occurring disease, divided into two types: seasonal and perennial. With the progress of industrialization, the drastic changes of modern lifestyle and human ecological environment, the incidence of allergic rhinitis has a global increasing trend. At present, there are mainly antihistamines such as chlorpheniramine, astemizole, and loratadine in the clinical treatment of allergic rhinitis in my country, and there are relatively few varieties. Chlorpheniramine has a strong sedative effect and can cause drowsiness and fatigue, and astemizole can cause severe cardiotoxicity. Nevertheless, these two varieties are still widely use...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 褚岩凤吴婷华赫侠平何添伊
Owner 扬子江药业集团江苏紫龙药业有限公司
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