Method for detecting impurities in freeze-dried powder injection of nedaplatin

A technology of freeze-dried powder injection and detection method, which is applied in the field of impurity detection of nedaplatin freeze-dried powder injection, can solve problems such as no improvement, and achieve the effects of avoiding hidden dangers, prolonging retention time, and improving durability

Active Publication Date: 2010-10-20
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0013] None of the existing known technologi

Method used

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  • Method for detecting impurities in freeze-dried powder injection of nedaplatin
  • Method for detecting impurities in freeze-dried powder injection of nedaplatin
  • Method for detecting impurities in freeze-dried powder injection of nedaplatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Instrument: SHIMADZULC-20AT high performance liquid chromatography;

[0041] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0042] Mobile phase: prepare a mixture with water-acetonitrile (volume ratio 80:20), add 0.1% diethylamine in the total volume of the mixture to the mixture;

[0043] Column temperature: 45°C;

[0044] Flow rate: 0.5ml / min;

[0045] Detection wavelength: 220nm.

[0046] Preparation of sample solution: The nedaplatin freeze-dried powder injection sample was prepared to contain nedaplatin 1mg / ml by using a mixed solvent of water and methanol (volume ratio of 50:50, and adjusting the pH to 5.6 with 0.05mol / L phosphoric acid). solution, filtered and stored at 8°C in the dark;

[0047] Determination: Inject 5 μL of sample solution into a high-performance liquid chromatograph, record and analyze the chromatogram, see figure 1 . The test results showed that the impurities were well separated.

Embodiment 2

[0049] Instrument: SHIMADZULC-20AT high performance liquid chromatography;

[0050] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0051] Mobile phase: prepare a mixture with water-acetonitrile (volume ratio 90:10), add 0.005% triethylamine of the total volume of the mixture to the mixture;

[0052] Column temperature: 40°C;

[0053] Flow rate: 1.0ml / min;

[0054] Detection wavelength: 210nm.

[0055] Preparation of sample solution: Nedaplatin freeze-dried powder injection samples were prepared to contain nedaplatin 0.5mg / ml by using a mixed solvent of water and methanol (volume ratio of 50:50, and adjusting the pH to 5.6 with 0.05mol / L phosphoric acid) solution, filtered and stored at 8°C in the dark;

[0056] Determination: Inject 20 μL of the sample solution into a high-performance liquid chromatograph, record and analyze the chromatogram, and the test results show that the impurities are well separated.

Embodiment 3

[0058] Instrument: SHIMADZULC-20AT high performance liquid chromatography;

[0059] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0060] Mobile phase: prepare a mixture with water-methanol (volume ratio 70:30), add 0.05% diethylamine in the total volume of the mixture to the mixture;

[0061] Column temperature: 30°C;

[0062] Flow rate: 0.8ml / min;

[0063] Detection wavelength: 205nm.

[0064] Preparation of sample solution: The nedaplatin freeze-dried powder injection sample was prepared to contain nedaplatin 2mg / ml by using a mixed solvent of water and methanol (volume ratio of 50:50, and adjusting the pH to 5.6 with 0.05mol / L phosphoric acid). solution, filtered and stored at 2°C in the dark;

[0065] Determination: Inject 5 μL of the sample solution into a high-performance liquid chromatograph, record the chromatogram and analyze it. The test results show that the impurities are well separated.

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Abstract

The invention relates to a method for detecting impurities in a freeze-dried powder injection of nedaplatin. In particular, the method comprises the following steps of: 1. adoption of a high performance liquid chromatography, wherein the chromatographic conditions are as follows: octyl chemically bonded silica is used as a bulking agent, a mobile phase is a mixture of water and acetonitrile or methanol, into which diethylamine or triethylamine is added, the detection wavelength is 205 to 222nm, the column temperature is between 20 and 45 DEG C, and the flow rate of the mobile phase is 0.5 to 2.0ml/min; 2. sample solution preparation, wherein the solution of the freeze-dried powder injection sample of nedaplatin, of which the nedaplatin content is 0.5 to 2mg/ml, is prepared by using a mixed solvent of water and methanol; and 3. measurement, wherein 5 to 20 micro liters of the sample solution is poured into a high performance liquid chromatograph, and chromatograms are recorded for analysis. By the method, the interference of skeleton excipient dextran with impurity detection is eliminated, and the impurities in nedaplatin raw materials can be easily, quickly and stably detected while the cost is lowered.

Description

technical field [0001] The invention relates to a method for detecting impurities of nedaplatin freeze-dried powder injection, more specifically, a method for detecting impurities in the production process of nedaplatin freeze-dried powder injection or in the final product by high performance liquid chromatography. Background technique [0002] Nedaplatin is an antineoplastic drug that was approved for marketing in June 1995 for the treatment of head and neck tumors, small cell and non-small cell lung cancer, esophageal cancer, bladder cancer, testicular cancer, ovarian cancer, and cervical cancer. The toxicity profile of Nedaplatin is different from that of cisplatin, and its dose-limiting toxicity is thrombocytopenia caused by myelosuppression. However, its nephrotoxicity and gastrointestinal side effects are reduced compared with cisplatin, and it has no cross-resistance, selective drug release and good solubility. In clinical trials, it was found that nedaplatin is effe...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 张建义赵小伟叶东王长斌戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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