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Method for detecting antipyrine related substances

A detection method and technology for related substances, which can be applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of inability to achieve baseline separation between main components and adjacent impurities, and large baseline interference, and achieve great practical significance, academic value, and sensitivity. High and cost saving effect

Active Publication Date: 2020-10-30
BEIJING SAISHENG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the chromatographic column (specification: 4.6*250mm, 5μm) using this filler is used for experimental exploration, the baseline interference is large, and the baseline separation of the main component and adjacent impurities cannot be achieved

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  • Method for detecting antipyrine related substances
  • Method for detecting antipyrine related substances
  • Method for detecting antipyrine related substances

Examples

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Embodiment 1

[0041] This embodiment provides a HPLC chromatographic analysis and detection method for antiangitide-related substances, and the specific steps are as follows:

[0042] 1. [Preparation of samples to be tested]

[0043] Test product solution: Weigh an appropriate amount of antiangitide to be tested, add water to dissolve and dilute to make a solution containing about 0.5 mg of antiangitide per 1 ml.

[0044] Hydrolysis destroys the sample solution: take the test solution and place it at room temperature for 72 hours.

[0045] Acid-destroyed sample solution: Weigh an appropriate amount of antiangitide for the sample to be tested, add 1ml of 2M hydrochloric acid solution, let it stand for 6 hours, add 1ml of 2M sodium hydroxide solution to stop the destruction, and finally add water to dilute to make each 1ml contain about antiangitide Peptide 0.5 mg solution.

[0046] Detection limit concentration solution: Weigh an appropriate amount of antiangitide reference substance, add ...

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Abstract

The invention belongs to the field of drug detection, and particularly relates to a method for detecting antipyrine related substances. The detection method comprises the following steps: taking an antipyrine peptide to-be-detected product to prepare a test solution, then taking a phosphate buffer solution as a mobile phase A and an acetonitrile aqueous solution as a mobile phase B to carry out HPLC detection, and taking diphenyl bonded silica gel as a filler for a chromatographic column of the HPLC detection. By establishing the detection method of the antipyrine related substances with highsensitivity, specificity, stability and durability, the quality of the antipyrine can be effectively controlled, and the quality of the antipyrine is stable, controllable and safe.

Description

technical field [0001] The invention belongs to the field of drug detection, and in particular relates to a method for detecting antiangitide-related substances. Background technique [0002] Antiangitide is a synthetic peptide of integrin blocker. Studies have found that it can effectively inhibit the migration of endothelial cells, but has no effect on tumor cell proliferation. Its synthesis process adopts the solid-term synthesis method, using Fmoc-Asp(Otbu)-wangresin as the starting material, and then using protected amino acids to sequentially connect dipeptide to octadecapeptide. In the process, there is a lack of effective intermediate process control, resulting in The rate is low and the process stability is poor. [0003] As a class of innovative drugs, antiangitide has not yet been recorded in domestic and foreign pharmacopoeias for its quality standards. In the current quality standards for polypeptide drugs, most of the detection methods for related substances ...

Claims

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Application Information

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IPC IPC(8): G01N30/34G01N30/56
CPCG01N30/34G01N30/56Y02A50/30
Inventor 滕宁宁吕晓利张甲姝赵佳欣马胜楠梁东娜赵光超梁丽娜
Owner BEIJING SAISHENG PHARMA
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