A kind of high performance liquid chromatography analysis and detection method of picantron maleate

A technology of picantone maleate and high-performance liquid chromatography, which is applied in the direction of analyzing materials, measuring devices, and material separation, can solve problems such as difficult separations, and achieve the effects of solving difficult separations, satisfactory separation, and easy operation
CN105699548BActive Publication Date: 2017-07-21HAINAN GENERAL & KANGLI PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HAINAN GENERAL & KANGLI PHARMA
Publication Date
2017-07-21

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Abstract

The invention belongs to the technical field of analysis and detection methods for antitumor drugs and particularly discloses a method for analysis and detection of maleic acid pixantrone through high performance liquid chromatography. A prepared solution with the concentration of maleic acid pixantrone being 0.1-1 mg / ml is injected in a high performance liquid chromatographic column with alkylsilane bonded silica gel as filler, a flow phase composed of a water solution containing sodium heptanesulfonate, dioxane and a chromatographically pure organic solvent is used for washing and separation, and then 240-250 nm ultraviolet light is used for analysis and detection. The method can be used for analysis and detection of the purity and relevant impurities of maleic acid pixantrone as well as quality control over maleic acid pixantrone and pharmaceutical preparations with maleic acid pixantrone as a main medicinal ingredient in the production, inspection and storage process. According to the method, a certain amount of dioxane is added into the flow phase creatively for the first time, the problem that it is hard to separate a main peak and impurity peaks and separate the adjacent impurity peaks is thoroughly solved, operation is easy and convenient, the separation degree is high, sensitivity is high, and accuracy is good.
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Description

Technical field

[0001] The present invention relates to the technical field of analysis and detection methods for anti-tumor drugs, in particular to a high-performance liquid chromatography analysis and detection method of pishantron maleate, that is, to analyze and detect the purity of pishantron maleate by high-performance liquid chromatography and relative substance. Background technique

[0002] Picanone maleate: The chemical name is 6,9-bis[(2-aminoethyl)amino]benzo[G]isoquinoline-5,10-dione dimaleate, and the molecular weight is 557.5.

[0003] The structural formula of Pishancin maleate is:

[0004]

[0005] Pishantron maleate is marketed by Cell Therapeutics (Nasdaq: CTIC), a cell therapy company based in Seattle, a biotechnology company. This product was originally synthesized by Novuspharma in Italy in 2003, and then Cell Therapeutics modified the compound to reduce the toxicity to the heart, and this toxicity would limit the dose and effectiveness of existing anthracycli...

Claims

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