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Dexrazoxane related substances and detection method thereof

A detection method and a technology for related substances, which are applied in the detection field, can solve the problems such as the lack of quality detection standards for dexrazoxane preparations, the inability to control the quality, and the lack of species, and achieve good system applicability and specificity, good linearity, and accuracy. Good effect of degree and durability

Active Publication Date: 2021-11-12
SICHUAN HUIYU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Dexrazoxane is sensitive to alkaline conditions and oxidation conditions, but the existing literature only reports the degradation process under alkaline hydrolysis conditions, and there is no report on the oxidation process of dexrazoxane, which leads to the currently known dexrazoxane-related Most of the substances are limited to degrading impurities, and there are few types, which makes the quality control of dexrazoxane have certain limitations. At present, the standards of various countries do not include the quality inspection standards of dexrazoxane and its preparations, so it is impossible to carry out strict quality control. control

Method used

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  • Dexrazoxane related substances and detection method thereof
  • Dexrazoxane related substances and detection method thereof
  • Dexrazoxane related substances and detection method thereof

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Embodiment 1

[0101] The screening of embodiment 1 chromatographic conditions

[0102] Screening of organic phase and elution procedure:

[0103] Condition 1:

[0104] Chromatographic column: YMC-Triart-C18, 4.6×250mm, 5μm;

[0105] Mobile phase: Phase A: phosphate buffer (0.01mol / L sodium dihydrogen phosphate aqueous solution, adjust pH to 2.2±0.05 with phosphoric acid), phase B: methanol, gradient elution program:

[0106] table 5

[0107] time / min Mobile phase A / vol.% Mobile phase B / vol.% 0 100 0 8.0 100 0 8.1 90 10 40.0 90 10 41.0 100 0 50.0 100 0

[0108] Column temperature: 30°C

[0109] Detection wavelength: 208nm;

[0110] Injection volume: 10μL;

[0111] Sample temperature: 5°C;

[0112] Diluent: Phosphate buffer (0.01mol / L sodium dihydrogen phosphate aqueous solution is adjusted to pH 1.5 with phosphoric acid, cooled to 2-8°C for use);

[0113] Test solution: resolution solution with a concentration of 1 mg / mL (prepared...

Embodiment 2

[0170] Embodiment 2 forced degradation test analysis

[0171] In order to verify that the detection method of the present invention can be applied to the quality control of dexrazoxane at various stages, the sample of dexrazoxane for injection is subjected to a forced degradation test, and the experimental method is as follows:

[0172] Acid destruction: Weigh about 55 mg of dexrazoxane sample for injection, put it in a 10 ml measuring bottle, add 4 ml of 1M hydrochloric acid aqueous solution, and place it at room temperature for 24 hours;

[0173] Alkali destruction: Weigh about 55 mg of dexrazoxane sample for injection, put it in a 10 ml measuring bottle, add 3 ml of 0.1M NaOH aqueous solution, and place it at room temperature for 10 minutes;

[0174] Oxidative damage: weigh about 55 mg of dexrazoxane for injection, put it in a 10 ml measuring bottle, add 1.5 ml of 0.3% hydrogen peroxide solution, and place it at room temperature for 1.5 hours;

[0175] High-temperature des...

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Abstract

The invention discloses dexrazoxane related substances and a detection method thereof, and provides four new oxidation impurities of dexrazoxane: an oxidation impurity 1, an oxidation impurity 2, a chromogenic impurity 1 and a chromogenic impurity 2; the related substances are qualitatively or / and quantitatively detected by adopting a high performance liquid chromatography method; the detection conditions of the liquid chromatography comprise that a chromatographic column is C18 or an equivalent chromatographic column; mobile phases comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is a phosphoric acid buffer solution, the mobile phase B is a mixed solution of the phosphoric acid buffer solution and acetonitrile in a volume ratio of (80-90):(10-20), and gradient elution is carried out. By adopting the method disclosed by the invention, nine related substances of dexrazoxane can be effectively detected at the same time, and verification experiments of system applicability, specificity, accuracy, precision, linear range, quantitation limit detection limit and durability show that the method can achieve the purpose of accurate quantitative analysis, and more strict quality control of dexrazoxane is facilitated.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to related substances of dexrazoxane and a detection method thereof. Background technique [0002] Dexrazoxane, also known as dexrazoxane, is the d-isomer of razoxane and is the only adjuvant approved by the US FDA for the treatment of DIC (disseminated or diffuse intravascular coagulation) coagulation, DIC). [0003] Dexrazoxane can quickly penetrate the cell membrane, be hydrolyzed into TCRE-198 in the cell, and then chelate with intracellular iron to reduce the complexes of ferric ions and anthracycline antineoplastic drugs such as doxorubicin, preventing The formation of free radicals reduces the cardiotoxicity of anthracycline antitumor antibiotics such as doxorubicin. Dexrazoxane can also inhibit the cytotoxicity produced by topoisomerase II, and in animal models, it can enhance or antagonize the cytotoxicity of some antitumor drugs. Studies have shown that dexrazoxane can ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/047
Inventor 张瑜丁兆胡和平李彬
Owner SICHUAN HUIYU PHARMA
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