Method for detecting relevant substances of cetirizine hydrochloride granules

A technology of cetirizine hydrochloride and related substances, which is applied in the field of detection of related substances in cetirizine granules, and achieves the effects of simple operation, enhanced retention time and good specificity

Active Publication Date: 2015-03-25
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

By adopting this technical means, it effectively overcomes the influence of related substances due to the poor retention behavior of cetirizine hydrochloride in ordinary reversed-phase chromatographic columns (such as octadecylsilane-bonded silica gel as a packing material). The problem of the specificity of the detection method has achieved good specificity, precision and accuracy, and the operation is simple

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  • Method for detecting relevant substances of cetirizine hydrochloride granules
  • Method for detecting relevant substances of cetirizine hydrochloride granules
  • Method for detecting relevant substances of cetirizine hydrochloride granules

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Embodiment Construction

[0017] A kind of cetirizine hydrochloride granule related substance detection method provided by the invention is characterized in that:

[0018] Using high performance liquid chromatography;

[0019] The chromatographic column is a phenyl column;

[0020] The detector is an ultraviolet detector with a detection wavelength of 231±4nm;

[0021] A mixed solution of acetonitrile and ammonium acetate buffer solution with a volume ratio of 2:8 to 4:6, more preferably 3:7, as the mobile phase;

[0022] Inject 50 μ L of 0.5% cetirizine hydrochloride control solution and test solution respectively for determination, elute isocraticly, record the chromatogram, and calculate the content of related substances of cetirizine hydrochloride granule with external standard method.

[0023] The length of said phenyl column is 100mm-250mm, which can be Agilent Eclipse XDB phenyl, 4.6mm×250mm, 5μm.

[0024] The method for preparing the ammonium acetate buffer solution described therein can be ...

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Abstract

The invention provides a method for detecting relavant substances of cetirizine hydrochloride granules. The detection method is characterized in that a phenyl column is adopted, the phenyl column is an Agilent Eclipse XDB phenyl 5-micrometer chromatographic column in the area of 4.6mm*250mm; a mixed solution of acetonitrile and ammonium acetate buffer solution in a volume ratio of (2: 8) to (4: 6) is adopted as a flow phase, isocratic elution is carried out on a high-efficiency liquid phase chromatographic instrument, and the relevant substances of the cetirizine hydrochloride granules are detected by utilizing an ultraviolet detector. The detection method is good in sensitivity, specificity, precision and accuracy, simple to operate and suitable for detecting relevant substances of the cetirizine hydrochloride granules.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, in particular to a method for detecting related substances of cetirizine granules. Background technique [0002] Cetirizine hydrochloride, chemical name (+ / -)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride Salt, its structural formula is as follows: [0003] [0004] It is a new generation of high-efficiency non-sedating antihistamines for the treatment of histamine-induced seasonal, perennial allergic rhinitis, itchy eyes and skin, and chronic idiopathic urticaria. Compared with other antihistamines, Although the central nervous system activity of cetirizine hydrochloride is low. At present, there are many dosage forms of cetirizine hydrochloride on the market in China, such as cetirizine hydrochloride dispersible tablets, cetirizine hydrochloride tablets, cetirizine hydrochloride capsules, cetirizine hydrochloride oral liquid and other dosage...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 杨红英宋学志黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD
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