Method for separating and measuring levocetirizine dihydrochloride and related substances by using high performance liquid chromatography

A technology of levocetirizine hydrochloride and high performance liquid chromatography, applied in the field of medical analysis, can solve the problems of inability to accurately quantify, interfere with the detection of levocetirizine lactose ester, etc., and achieve improved efficiency, strong specificity, and good separation. Effect

Active Publication Date: 2020-01-24
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] The test was carried out with reference to the imported registration standard method JX20120199, and it was found that the solvent peak interfered with the detection of levocetirizine lactose ester; the tailing factors of levocetirizine were all greater than 2.0; levocetirizine polyethylene glycol overlapped with the main peak, cannot be quantified accurately

Method used

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  • Method for separating and measuring levocetirizine dihydrochloride and related substances by using high performance liquid chromatography
  • Method for separating and measuring levocetirizine dihydrochloride and related substances by using high performance liquid chromatography
  • Method for separating and measuring levocetirizine dihydrochloride and related substances by using high performance liquid chromatography

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Experimental program
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Effect test

Embodiment 1

[0072] Embodiment 1 The inventive method detects related substances in levocetirizine hydrochloride tablets

[0073] The chromatographic column is a C18 chromatographic column (150mm×4.6mm, 5μm); the mobile phase is sodium heptanesulfonate solution: acetonitrile=62:38, the preparation method of sodium heptanesulfonate solution is to take 1.0g sodium heptanesulfonate, add water Dissolve and dilute to 1000ml, add 0.3ml triethylamine, adjust pH value to 3.5 with 0.5mol / L sulfuric acid solution.

[0074] Preparation of the test solution: take 10 tablets of this product, put them in a 200ml measuring bottle, add about 160ml of mobile phase, shake to dissolve levocetirizine hydrochloride, dilute to the mark with mobile phase, shake well, filter, and take the subsequent filtrate As the test solution;

[0075] Reference substance solution preparation: Accurately weigh cetirizine hydrochloride lactose ester reference substance, p-chlorobenzhydryl piperazine reference substance, cetiri...

Embodiment 2

[0082] Example 2 This method detects related substances in levocetirizine hydrochloride tablets

[0083] The chromatographic column is a C18 chromatographic column (150mm×4.6mm, 5μm); the mobile phase is sodium heptanesulfonate solution: acetonitrile=62:38, the preparation method of sodium heptanesulfonate solution is to take 1.0g sodium heptanesulfonate, add water Dissolve and dilute to 1000ml, add 0.3ml diethylamine, adjust pH value to 3.5 with 0.5mol / L sulfuric acid solution.

[0084] Need testing solution and reference substance solution are consistent with embodiment 1.

[0085] Get need testing solution, each 20ul of reference substance solution inject liquid chromatograph respectively, carry out elution by chromatographic condition of the present invention, the flow velocity of mobile phase is 1.5ml / min, and detection wavelength is 230mg, and chromatographic column column temperature is 30 ℃, Record the chromatogram, attached Image 6 . Details are shown in Table 10 ...

Embodiment 3

[0091] Example 3 This method detects related substances in levocetirizine hydrochloride tablets

[0092] The chromatographic column is a C18 chromatographic column (150mm×4.6mm, 5μm); the mobile phase is sodium heptanesulfonate solution: acetonitrile=62:38, the preparation method of sodium heptanesulfonate solution is to take 1.0g sodium heptanesulfonate, add water Dissolve and dilute to 1000ml, add 0.3ml ammonia water, adjust pH value to 3.5 with 0.5mol / L sulfuric acid solution.

[0093] Need testing solution and reference substance solution are consistent with embodiment 1.

[0094] Get need testing solution, each 20ul of reference substance solution inject liquid chromatograph respectively, carry out elution by chromatographic condition of the present invention, the flow velocity of mobile phase is 1.5ml / min, and detection wavelength is 230mg, and chromatographic column column temperature is 30 ℃, Record the chromatogram, attached Figure 7 . Details are shown in Table 1...

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Abstract

The invention relates to a method for separating and measuring levocetirizine dihydrochloride and 5 related substances by using high performance liquid chromatography. According to the method, a chromatographic column is a C18 chromatographic column, detection is performed after the elution of a mobile phase containing a mixed solution of sodium heptanesulfonate and acetonitrile, and alkali is added to the mobile phase. By adopting the method, separation and detection can be simultaneously performed any one or more of 5 related substances in a levocetirizine dihydrochloride tablet, that is, levocetirizine dihydrochloride, levocetirizine lactose ester thereof, levocetirizine polyethylene glycol ester, p-chlorobenzophenone, p-chlorobenzyl alcohol and p-chlorodiphenylmethylpiperazine. Compared with the prior art, the degree of separation of the levoctirizine hydrochloride and the related substances is good, the sensitivity is high and the separation and detection efficiency is improved.

Description

technical field [0001] The invention belongs to the field of medical analysis, in particular to a method for separating and measuring related substances in levocetirizine hydrochloride by high performance liquid chromatography. Background technique [0002] Levocetirizine hydrochloride is a selective histamine H1 receptor antagonist and a new generation of highly effective non-sedating antihistamines. It is suitable for allergic rhinitis (including seasonal persistent allergic rhinitis and perennial persistent allergic rhinitis) and chronic idiopathic urticaria. Levocetirizine hydrochloride tablets are the first-line drug for selective antihistamines for the treatment of allergic rhinitis and urticaria due to their rapid onset of action and significant curative effect. [0003] The research on related substances is one of the key issues in the quality research of preparations. There are literature reports on the research on related substances of levocetirizine hydrochloride...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74G01N2030/062
Inventor 王甫英陈霞王湘武赵梅姣
Owner HUNAN JIUDIAN PHARMA
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