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A kind of impurity detection method of nedaplatin

A detection method, nedaplatin technology, applied in the field of HPLC analysis of nedaplatin, can solve problems affecting the accuracy of analysis, affecting the separation of impurities, interference, etc., to shorten the equilibrium time, avoid potential safety hazards, improve durability and Effect

Active Publication Date: 2022-04-05
SIMCERE ZAIMING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the above prior art, the HPLC analysis techniques of nedaplatin all adopt the method of isocratic elution. The disadvantage of these methods is that if multiple samples are analyzed at one time, the weak polar substance of the previous sample will not be washed out. Interference with the latter sample may affect the separation of impurities at the same time, and ultimately affect the accuracy of the entire analysis

Method used

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  • A kind of impurity detection method of nedaplatin
  • A kind of impurity detection method of nedaplatin
  • A kind of impurity detection method of nedaplatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1) Chromatographic conditions:

[0036] Instrument: Agilent1200HPLC

[0037] Chromatographic column: Octadecylsilane bonded silica gel column (AQ-C18, 4.6×250mm, 5μm)

[0038] Mobile phase A: 0.5% potassium dihydrogen phosphate (adjust pH 6.5 with ammonia water)

[0039] Mobile Phase B: Acetonitrile

[0040] time (min) mobile phase A mobile phase B 0 97 3 5 97 3 15 70 30 15.1 97 3 25 97 3

[0041] Column temperature: 30°C

[0042] Flow rate: 0.8ml / min

[0043] Detection wavelength: 220nm

[0044] Injection volume: 10ul

[0045] Analysis time: record the chromatogram to 3 times the retention time of the main component peak

[0046] Solvent: mobile phase A - mobile phase B (97:3)

[0047] 2) Sample preparation:

[0048] Take an appropriate amount of raw materials, add a solvent to make a solution containing 1.0 mg of nedaplatin per ml.

[0049] Take an appropriate amount of nedaplatin for injection, add a solvent t...

Embodiment 2

[0052] 1) Chromatographic conditions:

[0053] Instrument: Agilent1200HPLC

[0054] Chromatographic column: Octadecylsilane bonded silica gel column (4.6×250mm, 5μm)

[0055] Mobile phase A: 1% ammonium dihydrogen phosphate (triethylamine adjusted pH7.5)

[0056] Mobile phase B: methanol-acetonitrile (3:2)

[0057] time (min) mobile phase A mobile phase B 0 98 2 25 60 40 25.1 98 2 35 98 2

[0058] Column temperature: 25°C

[0059] Flow rate: 0.6ml / min

[0060] Detection wavelength: 220nm

[0061] Injection volume: 10ul

[0062] Analysis time: record the chromatogram to 3 times the retention time of the main component peak

[0063] Solvent: mobile phase A - mobile phase B (98:2)

[0064] 2) Sample preparation:

[0065] Take an appropriate amount of raw materials, add a solvent to make a solution containing 1.0 mg of nedaplatin per ml.

[0066] Take an appropriate amount of nedaplatin for injection, and add a solution containin...

Embodiment 3

[0069] 1) Chromatographic conditions:

[0070]Instrument: Agilent1200HPLC

[0071] Chromatographic column: Octadecylsilane bonded silica gel column (4.6×250mm, 5μm)

[0072] Mobile phase A: 1% ammonium dihydrogen phosphate (triethylamine to adjust pH7.0)

[0073] Mobile Phase B: Methanol

[0074] time (min) mobile phase A mobile phase B 0 95 5 5 95 5 25 60 40 25.1 98 2 30 95 5

[0075] Column temperature: 40°C

[0076] Flow rate: 1.0ml / min

[0077] Detection wavelength: 220nm

[0078] Injection volume: 20ul

[0079] Analysis time: record the chromatogram to 3 times the retention time of the main component peak

[0080] Solvent: mobile phase A - mobile phase B (95:5)

[0081] 2) Sample preparation:

[0082] Take an appropriate amount of raw materials, add a solvent to prepare a solution containing 1.5 mg of nedaplatin per ml.

[0083] Take an appropriate amount of nedaplatin for injection, and add a solvent to prepare a ...

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Abstract

The invention discloses an impurity HPLC analysis method for nedaplatin. In the method, octadecylsilane bonded silica gel is used as a filler (recommendation: AQ-C18), the detection wavelength is 205-222nm, and the column temperature is 20~45℃, the mobile phase is a mixture of pH6.0~8.5 buffer and polar organic solvent, characterized in that the mobile phase is to elute the impurities in the nedaplatin sample by gradient elution, pH6. The initial ratio of 0-8.5 buffer solution to polar organic solvent is 100:0-90:10, and the final ratio is 90:10-60:40; the flow rate of mobile phase is 0.5-1.0ml / min; prepared with mobile phase into a solution containing 0.5 mg to 2 mg / ml of nedaplatin; inject 5 μl to 20 μl of the sample solution into a high performance liquid chromatograph, record the chromatogram and perform sample analysis. After using the HPLC analysis method of the present invention, the theoretical plate number of the main peak of the product is obviously increased, and more impurities can be separated, so that the accuracy of analyzing the nedaplatin sample is improved.

Description

technical field [0001] The invention relates to an HPLC analysis method for nedaplatin. 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. In clinical trials, it was found that nedaplatin is effective for a wide range of solid tumors, which is better than cisplatin. The effective rate for esophageal cancer is greater than 50%, which is about 20% higher than that of cisplatin. It is also more than 40% effective for cervical cancer. For these patients Provides new and effective clinical options. [0003] The peak of the active ingredient in nedaplatin has a very short retention time in the general chromatographic test system, and the impurities are difficult to separate. Not only is the chromatographic test system poor in stability, reproduci...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 王霞李薇任晋生
Owner SIMCERE ZAIMING PHARM CO LTD
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