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Method for detecting related substances in levocetirizine hydrochloride oral solution

A technology of levocetirizine hydrochloride and oral solution, which is applied in the field of drug analysis and can solve undiscovered problems

Active Publication Date: 2021-12-28
浙江核力欣健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no detection method that can detect the above 5 impurities at the same time

Method used

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  • Method for detecting related substances in levocetirizine hydrochloride oral solution
  • Method for detecting related substances in levocetirizine hydrochloride oral solution
  • Method for detecting related substances in levocetirizine hydrochloride oral solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Impurity localization and separation:

[0062] Take p-hydroxybenzoic acid, levocetirizine amide, p-chlorobenzhydryl piperazine, levocetirizine hydrochloride, methylparaben, propylparaben, p-chlorobenzhydryl alcohol, p-chlorodiphenyl For ketone, use acetonitrile-water (1:1) to make a mixed solution of the reference substance. The concentration of each raw material in the mixed solution of the obtained reference substance is: p-hydroxybenzoic acid 1 μg / ml, levocetirizine amide 0.4 μg / ml, p-chlorobenzhydrylpiperazine 0.4 μg / ml, levocetirizine hydrochloride 0.1mg / ml, 0.135mg / ml methylparaben, 0.015mg / ml propylparaben, 0.4μg / ml p-chlorobenzophenone, 0.4μg / ml p-chlorobenzophenone.

[0063] Chromatographic conditions

[0064] The chromatographic conditions of high performance liquid chromatography are as follows:

[0065] Instrument: Agilent 1260 high performance liquid chromatography;

[0066] Chromatographic column: Octane-bonded silica gel is used as filler, and the chr...

Embodiment 2

[0085] Accuracy

[0086] Chromatographic conditions

[0087] The chromatographic conditions of high performance liquid chromatography are as follows:

[0088] Instrument: Agilent 1260 high performance liquid chromatography;

[0089] Chromatographic column: Octane-bonded silica gel is used as filler, and the chromatographic column model is Agilent SB-C8, 250mm×4.6mm, 5μm;

[0090] Mobile phase: Potassium dihydrogen phosphate buffer is mobile phase A, the concentration of potassium dihydrogen phosphate in the potassium dihydrogen phosphate buffer is 30mmol / L, and the pH value is adjusted to 3.0 with phosphoric acid; acetonitrile is used as mobile phase B;

[0091] Flow rate: 1.0ml / min;

[0092] Wavelength: 230nm

[0093] Running time: 50min;

[0094] Column temperature: 30°C;

[0095] Injection volume: 20μL;

[0096] The gradient elution program is:

[0097] 0~14min: mobile phase A 65%, mobile phase B 35%;

[0098] 14~35min: Mobile phase A is reduced from 65% to 30% at ...

Embodiment 3

[0122] precision

[0123] The chromatographic conditions of high performance liquid chromatography are as follows:

[0124] Instrument: Agilent 1260 high performance liquid chromatography;

[0125] Chromatographic column: Octane-bonded silica gel is used as filler, and the chromatographic column model is Agilent SB-C8, 250mm×4.6mm, 5μm;

[0126] Mobile phase: Potassium dihydrogen phosphate buffer is mobile phase A, the concentration of potassium dihydrogen phosphate in the potassium dihydrogen phosphate buffer is 30mmol / L, and the pH value is adjusted to 3.0 with phosphoric acid; acetonitrile is used as mobile phase B;

[0127] Flow rate: 1.0ml / min;

[0128] Wavelength: 230nm

[0129] Running time: 50min;

[0130] Column temperature: 30°C;

[0131] Injection volume: 20μL;

[0132] The elution gradient is:

[0133] 0~14min: mobile phase A 65%, mobile phase B 35%;

[0134] 14~35min: Mobile phase A is reduced from 65% to 30% at a constant speed, and mobile phase B is incr...

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Abstract

The invention provides a method for detecting related substances in a levocetirizine hydrochloride oral solution, belongs to the technical field of pharmaceutical analysis, and the method comprises the following steps: adopting a high performance liquid chromatography to detect the related substances in the levocetirizine hydrochloride oral solution, and calculating the content of related substances in the levocetirizine hydrochloride oral solution by using an external standard method. According to the method, acetonitrile and a monopotassium phosphate buffer solution are used as mobile phases, gradient elution is performed on a high performance liquid chromatograph, and parachlorobenzhydrol, parachlorobenzophenone, parachlorobenzhydryl piperazine, levocetirizine amide and p-hydroxybenzoic acid can be accurately and efficiently detected at a time under a liquid phase condition.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting related substances in levocetirizine hydrochloride oral solution. Background technique [0002] Levocetirizine hydrochloride is the active R-type single optical isomer of the second-generation antihistamine cetirizine widely used in clinical practice. It is a new generation of oral selective histamine H1 receptor antagonist with high efficiency and no sedative side effects. It has no obvious anticholinergic and anti-serotonin effects, and has a small central inhibitory effect. It is used for the treatment of allergic diseases such as urticaria, allergic rhinitis, eczema, dermatitis, and pruritus. [0003] During the synthesis process of raw materials of levocetirizine hydrochloride and the production and storage of oral solutions, 5 kinds of impurities will be produced, among which p-chlorobenzhydrylpiperazine and levocetirizinamide are important comp...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
Inventor 张文杰李耀湘刘佳伟陈刘进
Owner 浙江核力欣健药业有限公司
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