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Method for detecting impurities in nedaplatin

A detection method, nedaplatin technology, applied in the field of inspection of nedaplatin raw material impurities, can solve problems such as no improvement, and achieve the effects of avoiding hidden dangers, stable detection, and prolonging retention time

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

AI Technical Summary

Problems solved by technology

[0013] None of the existing known technologies propose improvements to the above defects

Method used

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  • Method for detecting impurities in nedaplatin
  • Method for detecting impurities in nedaplatin
  • Method for detecting impurities in nedaplatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Instrument: SHIMADZULC-20AT high performance liquid chromatography;

[0038] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0039] Mobile phase: prepare a water-acetonitrile mixture (volume ratio water: acetonitrile = 70:30), add 0.05% triethylamine in the total volume of the mixture to the water-acetonitrile mixture;

[0040] Column temperature: 40°C;

[0041] Flow rate: 1.0ml / min;

[0042] Detection wavelength: 220nm.

[0043] Preparation of sample solution: Prepare the sample into a solution containing 1 mg / ml of nedaplatin with mobile phase, and store it in the dark at 6°C;

[0044] Determination: Inject 10 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

[0046] Instrument: SHIMADZULC-10AT high performance liquid chromatography;

[0047] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0048] Mobile phase: prepare a mixture with water-acetonitrile (volume ratio 60:40), add 0.005% diethylamine in the total volume of the mixture;

[0049] Column temperature: 20°C;

[0050] Flow rate: 0.5ml / min;

[0051] Detection wavelength: 215nm.

[0052] Preparation of sample solution: use mobile phase to prepare the sample into a solution containing 0.5 mg / ml of nedaplatin, and store it in the dark at 8°C;

[0053] 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

[0055] Instrument: SHIMADZULC-20AT high performance liquid chromatography;

[0056] Chromatographic column: octylsilane bonded silica gel column (4.6×250mm, 5μm);

[0057] Mobile phase: prepare a mixture with water-methanol (volume ratio 80:20), add 0.1% triethylamine of the total volume of the mixture to the mixture;

[0058] Column temperature: 45°C;

[0059] Flow rate: 1.2ml / min;

[0060] Detection wavelength: 210nm.

[0061] Preparation of sample solution: use mobile phase to prepare the sample into a solution containing 2 mg / ml of nedaplatin, and store it in the dark at 2°C;

[0062] 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 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 a solution of the sample, of which the nedaplatin content is 0.5 to 2mg / ml, is prepared by using the mobile phase, and the obtained solution is stored in a dark place at the temperature of between 2 and 8 DEG C; 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 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 testing impurities of nedaplatin raw materials, more specifically a method for detecting impurities in the production process of nedaplatin or in nedaplatin products 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 effective for a wide range of solid tumors, with an...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/36
Inventor 赵俊戴建国叶东赵卉戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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