Method for detecting related substances in cetirizine hydrochloride sample

A technology of cetirizine hydrochloride and related substances, which is applied in the field of medicine, can solve problems such as detection methods that need to be improved, and achieve the effects of rapid detection, simple operation, and short analysis time

Active Publication Date: 2018-03-09
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] At present, the detection methods for related substance

Method used

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  • Method for detecting related substances in cetirizine hydrochloride sample
  • Method for detecting related substances in cetirizine hydrochloride sample
  • Method for detecting related substances in cetirizine hydrochloride sample

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] In this embodiment, according to the configuration method and test conditions basically the same as the general method, 10 microliters of the diluted solution was taken and injected into a high-performance liquid chromatograph for detection.

[0058] This embodiment detects the chromatogram of the diluted solution that obtains, as figure 1 shown. Depend on figure 1 It can be seen that the dilute solution only has two obvious solvent peaks after the residence time is greater than 40min, and the diluent has no absorption peak at the retention time of the main peak and each impurity peak, and there is only a gradient peak on the spectrum, so there is no interference.

Embodiment 2

[0060] In this embodiment, according to the configuration method and test conditions basically the same as the general method, 10 microliters of the reference substance solution was taken and injected into a high-performance liquid chromatograph for detection. In this way, whether the components of the dilute solution will interfere with the peak position of cetirizine hydrochloride.

[0061] This embodiment detects the chromatogram of the cetirizine hydrochloride reference substance solution that obtains, as figure 2 shown. Depend on figure 2 It can be seen that the peak position of cetirizine hydrochloride appears near the retention time of 13.1min, and the two solvent peaks of the dilute solution will not interfere with the main peak of cetirizine hydrochloride.

Embodiment 3

[0063] In this embodiment, according to the configuration method and test conditions basically the same as the general method, 10 microliters of sample solution is taken and injected into a high-performance liquid chromatograph for detection.

[0064] The chromatogram of the cetirizine hydrochloride sample solution that this embodiment detects obtains, as image 3 shown. Depend on image 3 It can be seen that, except for the main peak of cetirizine hydrochloride with a residence time of around 13.0min, three known related substances were detected, namely, Cetirizine Glycero Ester with a residence time of around 10.7min, and Cetirizine Glycero Ester with a residence time of around 11.3min Cetirizine ethanol and 4-Chlorophenone with a residence time of around 38.7min; and two unknown related substances with a residence time of around 9.0min and around 32.1min, respectively.

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Abstract

The invention provides a method for detecting related substances in a cetirizine hydrochloride sample. The detection method comprises the following steps: using high performance liquid chromatographyto detect the cetirizine hydrochloride sample, wherein the mobile phase of the high performance liquid chromatography comprises a mobile phase A which is an aqueous solution containing 0.05mol/L of sodium dihydrogen phosphate, and of which the pH value is 3.8 and a mobile phase B which is acetonitrile. The detection method of the related substances in the cetirizine hydrochloride sample provided by the invention can simply and quickly detect the related substances in the cetirizine hydrochloride sample and peaks can be separated effectively. The detection method is simple to operate and shorter in analysis time.

Description

technical field [0001] The invention relates to the field of medicine, and in particular, the invention relates to a method for detecting related substances in cetirizine hydrochloride samples. Background technique [0002] Cetirizine hydrochloride is a potent H1 receptor antagonist, which can be taken orally into the body, and can quickly bind to the histamine H1 receptor on the target cell membrane, and block the activation of target cells by histamine. Its chemical name is (±)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride, and its molecular weight is 461.82. The structural formula is as follows: [0003] [0004] At present, the detection methods for related substances in cetirizine hydrochloride samples still need to be improved. Contents of the invention [0005] The present invention aims to solve one of the technical problems in the related art at least to a certain extent. [0006] The present invention has been accomplishe...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/067
Inventor 文学智蔡波涛秦巨波郭云梅高婷李琳
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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