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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

Active Publication Date: 2017-07-21
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the above technical problems, the present invention creatively adds a certain amount of dioxane into the mobile phase for the first time, which completely solves the difficult problem of separation between the main peak and impurity peaks and adjacent impurity peaks, and is easy to operate, high in sensitivity and accurate it is good

Method used

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

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Experimental program
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Effect test

Embodiment 1

[0043] Chromatographic conditions: octadecyl silane-bonded silica gel is used as a filler, and the mobile phase is a mixture of water, acetonitrile and dioxane in a volume ratio of 75:20:5. After dissolving sodium heptane sulfonate, adjust the pH with phosphoric acid The solution obtained to 2.5 (1L mobile phase only needs to add 3 to 4 drops of phosphoric acid, so the amount of phosphoric acid has a negligible effect on the volume), the concentration of sodium heptane sulfonate in the mobile phase is 20mmol / L, and the flow rate is 1.2ml / min, detection wavelength 247nm, chromatographic column: Alltima C18 4.6×150mm, 5μm, column temperature 40℃, injection volume: 20μl.

[0044] Preparation of test solution:

[0045] Take about 50mg of Pishancin maleate raw material, accurately weigh it, place it in a 100ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake it well, as the test solution.

[0046] Take 20 μl of the above solution and inject it into the liquid...

Embodiment 2

[0049] Chromatographic conditions: octadecyl silane-bonded silica gel is used as a filler, and the mobile phase is a mixture of water, acetonitrile and dioxane in a volume ratio of 75:20:5. After dissolving sodium heptane sulfonate, adjust the pH with phosphoric acid To the solution obtained in 3.5, the concentration of sodium heptane sulfonate in the mobile phase is 20mmol / L, the flow rate is 1.2ml / min, the detection wavelength is 247nm, chromatographic column: Alltima C18 4.6×150mm, 5μm, column temperature 40℃, sample injection Quantity: 20μl.

[0050] Preparation of test solution:

[0051] Take about 50mg of Pishancin maleate raw material, accurately weigh it, place it in a 100ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake it well, as the test solution.

[0052] Take 20 μl of the above solution and inject it into the liquid chromatograph, record the chromatogram, and calculate the purity of Pishancin maleate by the area normalization method.

[005...

Embodiment 3

[0055] Chromatographic conditions: octyl silane-bonded silica gel is used as a filler, and the mobile phase is a mixture of water, acetonitrile and dioxane in a volume ratio of 75:20:5. After dissolving sodium heptane sulfonate, adjust the pH to 3.0 The solution obtained, the concentration of sodium heptane sulfonate in the mobile phase is 20mmol / L, the flow rate is 1.2ml / min, the detection wavelength is 247nm, the chromatography column: Agilent XDB-C84.6×250mm, 5μm, the column temperature is 40°C, Injection volume: 20μl.

[0056] Preparation of test solution:

[0057] Take about 50mg of Pishancin maleate raw material, accurately weigh it, place it in a 100ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake it well, as the test solution.

[0058] Take 20 μl of the above solution and inject it into the liquid chromatograph, record the chromatogram, and calculate the purity of Pishancin maleate by the area normalization method.

[0059] The HPLC analysis cha...

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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.

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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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/26
CPCG01N30/06G01N30/26G01N30/74
Inventor 汪旭东戴正琳钱良友余丹史自东
Owner HAINAN GENERAL & KANGLI PHARMA
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