Method for detecting dexrazodone and related substances thereof

A technology of dexrazoxane and detection method, applied in the field of detection, can solve the problems of background absorption interference response, less species, limited degradation of impurities, etc., to achieve good system applicability and specificity, good accuracy and durability, and ensure quality. safe effect

Active Publication Date: 2021-10-01
SICHUAN HUIYU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] First, ordinary chromatographic conditions are difficult to retain
The degradation impurities of dexrazoxane contain both carboxyl and amino bonds with very strong polarity. It is difficult to achieve retention and separation under ordinary reversed-phase chromatography conditions. It is usually considered to add ion-pairing reagents to improve retention, but it will introduce such as Problems with Interference Detection, Background Absorption Interference Response
[0007] Second, no purple absorption curve
Dexrazoxane does not contain conjugated bonds, and some degraded impurities even have no obvious absorption curve, which makes

Method used

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  • Method for detecting dexrazodone and related substances thereof
  • Method for detecting dexrazodone and related substances thereof
  • Method for detecting dexrazodone and related substances thereof

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Experimental program
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Embodiment 1

[0098] The screening of embodiment 1 chromatographic conditions

[0099] Screening of organic phase and elution procedure:

[0100] Condition 1:

[0101] Chromatographic column: YMC-Triart-C18, 4.6×250mm, 5μm;

[0102] 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:

[0103] table 5

[0104]

[0105]

[0106] Column temperature: 30°C

[0107] Detection wavelength: 208nm;

[0108] Injection volume: 10μL;

[0109] Sample temperature: 5°C;

[0110] 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);

[0111] Test solution: resolution solution with a concentration of 1 mg / mL (prepared with dexrazoxane for injection, and added with impurities A to D as a control solution);

[0112] Flow rate: 0.8mL / min.

[0113] Test results such as...

Embodiment 2

[0168] Embodiment 2 forced degradation test analysis

[0169] 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:

[0170] 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;

[0171] 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;

[0172] 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;

[0173] High-temperature des...

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Abstract

The invention discloses a method for detecting dexrazodone and related substances thereof, dexrazodone and/or related substances in dexrazodone or a preparation thereof are qualitatively or/and quantitatively detected by adopting a high performance liquid chromatography method, and the detection conditions of liquid chromatography are as follows: a chromatographic column is C18 or an equivalent chromatographic column; and mobile phases comprise a mobile phase A and a mobile phase B, 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, the dexrazolone and nine related substances in the dexrazolone 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 is beneficial to more strict quality control on the dexrazolone.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to a detection method of dexrazoxane and its related substances. 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 redu...

Claims

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Application Information

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IPC IPC(8): G01N30/32G01N30/06
CPCG01N30/32G01N30/06G01N2030/324G01N2030/065
Inventor 张瑜丁兆胡和平李彬
Owner SICHUAN HUIYU PHARMA
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