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A kind of method for separating and measuring levocetirizine hydrochloride and related substances by high performance liquid chromatography

A technology of levocetirizine hydrochloride and high performance liquid chromatography, which is applied in the field of medical analysis, can solve the problems of inaccurate quantification and interference with the detection of levocetirizine lactose ester, and achieve improved efficiency, strong specificity, and good separation Effect

Active Publication Date: 2022-07-01
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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  • A kind of method for separating and measuring levocetirizine hydrochloride and related substances by high performance liquid chromatography
  • A kind of method for separating and measuring levocetirizine hydrochloride and related substances by high performance liquid chromatography
  • A kind of method for separating and measuring levocetirizine hydrochloride and related substances by high performance liquid chromatography

Examples

Experimental program
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Effect test

Embodiment 1

[0072] Example 1 Detection of related substances in levocetirizine hydrochloride tablets by the method of the present invention

[0073] The chromatographic column is a C18 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 of sodium heptanesulfonate, add water Dissolve and dilute to 1000ml, add 0.3ml triethylamine, adjust pH to 3.5 with 0.5mol / L sulfuric acid solution.

[0074] Preparation of test solution: Take 10 tablets of this product, put it in a 200ml volumetric flask, add about 160ml of mobile phase, shake to dissolve levocetirizine hydrochloride, dilute to the mark with mobile phase, shake well, filter, and take the continuous filtrate as the test solution;

[0075] Reference substance solution preparation: Precisely weigh cetirizine hydrochloride lactose ester reference substance, p-chlorobenzylpiperazine reference substance, cetirizine polyet...

Embodiment 2

[0082] Example 2 Detection of related substances in levocetirizine hydrochloride tablets by this method

[0083] The chromatographic column is a C18 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 of sodium heptanesulfonate, add water Dissolve and dilute to 1000ml, add 0.3ml of diethylamine, adjust the pH value to 3.5 with 0.5mol / L sulfuric acid solution.

[0084] The test solution and reference solution were the same as those of Example 1.

[0085] Take each 20ul of the test solution and the reference solution and inject them into the liquid chromatograph respectively, and elute according to the chromatographic conditions of the present invention. The flow rate of the mobile phase is 1.5ml / min, the detection wavelength is 230mg, and the chromatographic column temperature is 30°C. Record the chromatogram, with Image 6 . Details are shown in Table ...

Embodiment 3

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

[0092] The chromatographic column is a C18 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 of 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] The test solution and reference solution were the same as those of Example 1.

[0094] Take each 20ul of the test solution and the reference solution and inject them into the liquid chromatograph respectively, and elute according to the chromatographic conditions of the present invention. The flow rate of the mobile phase is 1.5ml / min, the detection wavelength is 230mg, and the chromatographic column temperature is 30°C. Record the chromatogram, with Figure 7 . Details are shown in Table 12 and Table ...

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Abstract

The invention relates to a method for separating and measuring levocetirizine hydrochloride and five related substances by high-performance liquid chromatography. The chromatographic column of the method is a C18 chromatographic column. The mobile phase was eluted and detected, and alkali was also added to the mobile phase. The method can simultaneously quantify levocetirizine hydrochloride, levocetirizine lactose, levocetirizine polyethylene glycol ester, p-chlorobenzophenone, p-chlorodicarbonate in levocetirizine hydrochloride tablets at the same time. Any one or more of the five related substances of benzyl alcohol and p-chlorobenzylpiperazine are separated and detected. Compared with the prior art, the separation degree of levocetirizine hydrochloride and various related substances is better, 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. For allergic rhinitis (including seasonal persistent allergic rhinitis and perennial persistent allergic rhinitis) and chronic idiopathic urticaria. Levocetirizine hydrochloride tablet is the first-line drug for the treatment of allergic rhinitis and urticaria due to its rapid onset and remarkable curative effect. [0003] Research on related substances is one of the key issues in preparation quality research. There are literature reports on the research on related substances of levocetirizine hydrochloride tablets at home and abroad. According to literature research, levocet...

Claims

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Application Information

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Patent Type & Authority Patents(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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