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Method for detecting picoplatin and impurities thereof

A detection method and a technology of mediplatin are applied in the detection field of mediplatin and its impurities, and can solve the problems such as literature reports that the detection of mediplatin and its impurities has not been found yet.

Active Publication Date: 2012-07-18
KUNMING GUIYAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] So far, no literature reports on the detection of methylciplatin and its impurities have been found

Method used

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  • Method for detecting picoplatin and impurities thereof
  • Method for detecting picoplatin and impurities thereof
  • Method for detecting picoplatin and impurities thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Instrument: Waters 1525 high performance liquid chromatography;

[0027] Chromatographic column: octadecylsilane bonded silica gel (φ4.6×250mm, 5μm)

[0028] Mobile phase: Prepare a buffered saline solution of 0.002 mol / L sodium octane sulfonate and 0.01 mol / L potassium dihydrogen phosphate, adjust the pH value to 5.0, and the ratio of acetonitrile to 90:10;

[0029] Column temperature: 40°C;

[0030] Detection wavelength: 210nm;

[0031] Flow rate: 2.0ml / min;

[0032] Preparation of sample solution: Use pure water to prepare the sample into a solution containing 0.2 mg / mL of methylciplatinum, and inject the sample within 20 minutes.

[0033] Determination: Inject 10 μL of sample solution into a high-performance liquid chromatograph within 20 minutes, record and analyze the chromatograms, and the test results show that the separation of methoplatin and impurities is good. Chromatogram see figure 1 .

Embodiment 2

[0035] Instrument: Waters 1525 high performance liquid chromatography;

[0036] Chromatographic column: octadecylsilane bonded silica gel (φ4.6×250mm, 5μm)

[0037] Mobile phase: Prepare a buffered saline solution of 0.004 mol / L sodium octane sulfonate and 0.01 mol / L potassium dihydrogen phosphate, adjust the pH value to 5.0, and the ratio of acetonitrile to 90:10;

[0038] Column temperature: 40°C;

[0039] Detection wavelength: 210nm;

[0040] Flow rate: 2.0ml / min;

[0041] Preparation of sample solution: The sample was prepared into a solution containing 0.2 mg / ml of picoplatin with physiological saline, and stored in the dark.

[0042] Determination: Inject 10 μL of the sample solution into a high-performance liquid chromatograph, record and analyze the chromatograms, and the test results show that the peaks of picoplatin, impurities and solvents are well separated. Chromatogram see figure 2 .

Embodiment 3

[0044] Instrument: Waters 1525 high performance liquid chromatography;

[0045] Chromatographic column: octadecylsilane bonded silica gel (φ4.6×250mm, 5μm)

[0046] Mobile phase: Prepare a buffered saline solution of 0.006 mol / L sodium octane sulfonate and 0.015 mol / L potassium dihydrogen phosphate, adjust the pH value to 5.5, and the ratio of acetonitrile to 95:5;

[0047] Column temperature: 30°C;

[0048] Detection wavelength: 205nm;

[0049] Flow rate: 1.0ml / min;

[0050] Preparation of sample solution: The sample was prepared into a solution containing 0.2 mg / ml of picoplatin with physiological saline, and stored in the dark.

[0051] Determination: Inject 20 μL of the sample solution into a high-performance liquid chromatograph, record the chromatogram and analyze it. The test results show that the peaks of picoplatin, impurities and solvents are well separated under this condition.

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Abstract

The invention relates to a method for detecting an antitumor medicine, namely a picoplatin bulk medicine and impurities thereof. The method comprises the following specific steps of: 1, adopting high performance liquid chromatography, wherein the chromatographic conditions are that: octadecylsilane chemically bonded silica is used as filler; a flowing phase is a mixed solution of a buffer salt solution (pH is 4.0 to 6.0) of ocane sulfonic acid sodium, sodium heptanesulfonate or monopotassium phosphate and acetonitrile or methanol; the detection wavelength is 200 to 260nm; the column temperature is 25 to 45 DEG C; the flow speed of the flowing phase is 0.5 to 2.0ml / min; 2, preparing a sample solution, namely preparing a 0.1 to 0.3mg / ml solution containing picoplatin by using pure water or normal saline, and keeping in a dark place; and 3, determining, namely injecting 5 to 20 mu L of the sample solution into a high performance liquid chromatograph, recording a chromatogram and analyzing. By the method, the picoplatin can be detected, and the impurities in the picoplatin bulk medicine can be detected easily, quickly and flexibly.

Description

technical field [0001] The invention relates to a method for testing the antineoplastic drug meciplatin and its impurities, that is, a method for detecting mediplatin and its impurities through high-performance liquid chromatography. Background technique [0002] Methidine platinum is a platinum group metal complex and is a new generation of platinum-based antineoplastic drugs after cisplatin, carboplatin and oxaliplatin. Picoplatin, also known as JM473, AMD473, ZD0473, etc., English name Picoplatin, full name cis-dichloro-ammonia, (2-methylpyridine) platinum (II) [Cis-amminedichloro (2-methylpyridine)-platinum (II) )], molecular weight is 376.16, chemical structural formula: [0003] [0004] Methidine platinum was first jointly developed by Johnson Matthey Company of the United Kingdom, AnorMed Company of Canada and the British Institute of Cancer Research. It is a new type of platinum complex with steric hindrance effect. It shows good anti-tumor activity in vivo and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/36
Inventor 栾春芳丛艳伟普绍平张琪贝玉祥邱学翁何键李永年
Owner KUNMING GUIYAN PHARMA
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