Method for detecting dexrazodone and related substances thereof

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...

AI Technical Summary

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 it difficult to select the wavelength of ultraviolet detection, which may easily lead to distortion of product detection results and non-conservation of quality

[0008] Third, 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, resulting in the currently known dexrazoxane Most of the related substances of razoxane are limited to degradation impurities, and there are fewer types, which also leads to limitations in the quality control process of dexrazoxane

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