Eribulin and detection method of related substance in preparation containing Eribulin

A detection method and a technology related to substances, which are applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as interference, and achieve the effects of high separation, strong superiority, and simple operation

Inactive Publication Date: 2019-12-13
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method overcomes the problem that the drug does not have a uniform drug standard, solves the interference of various known or unknown impurities introduced by the synthesis process or generated by degradation and preparation processing on the determination of product purity, and better controls Eribulin products. the quality of

Method used

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  • Eribulin and detection method of related substance in preparation containing Eribulin
  • Eribulin and detection method of related substance in preparation containing Eribulin
  • Eribulin and detection method of related substance in preparation containing Eribulin

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 Determination of Eribulin Related Substances

[0025] 1. Chromatographic conditions and system suitability experiments

[0026] 1.1 Selection of chromatographic conditions:

[0027] Instrument: Agilent 1260, the optimum column temperature is 35°C, the flow rate is 1.0ml / min, and the detection wavelength is 254nm. Eclipse XDB-C18 column for liquid chromatography (150mm×4.6mm, 5μm), 0.01mol / L NH 4 OAc solution (pH5.0) - acetonitrile or 0.01mol / L NH 4 OAc solution (pH6.0)-methanol is the mobile phase composition, and its optimal ratio is: 10:90 (the mobile phase composition sequence is consistent with the volume ratio sequence). The injection volume is 20 μl.

[0028] Under this chromatographic condition, the main peak of eribulin had a moderate retention time and a good peak shape.

[0029] 1.2 Sensitivity determination

[0030] Take an appropriate amount of eribulin, use the mobile phase to prepare a solution with a concentration of 0.2 mg per 1 ml, an...

Embodiment 2

[0040] Embodiment Two: Determination of Related Substances in Eribulin Mesylate Injection

[0041] Get the test product, accurately measure an appropriate amount (approximately equivalent to eribulin 2 mg), add mobile phase to configure a solution containing 0.2 mg per 1 ml, filter, and take the diluted filtrate as the test product solution. Precisely measure an appropriate amount, add mobile phase to dilute to a solution containing about 2 μg per 1 ml, and use it as a control solution. Under the following selected chromatographic conditions:

[0042] UV detector (Agilent 1260) detection wavelength 254nm, Eclipse XDB-C18 column (150mm×4.6mm, 5 μm), 0.01mol / L NH 4 OAc solution (pH6.0)-acetonitrile composition, the optimal ratio is: 10:90. The column temperature of the chromatographic column is 30°C, and the flow rate is 1.0ml / min. The injection volume is 20 μl. The theoretical plate is not less than 3000 based on Eribulin peak.

[0043] The measurement results are shown in...

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Abstract

The invention discloses Eribulin and a detection method of related substance in a preparation containing the Eribulin. The method specifically comprises a step of quickly and accurately detecting theimpurity of the Eribulin and the degradation product condition by adopting a reverse-phase high-performance liquid chromatography, and the interference on the product purity by various impurities produced in the synthesis and preparation process is solved, and the quality of the raw medicine and the preparation can be comprehensively and reliably controlled. The method disclosed by the invention is simple in operation, good in sensitivity, good in separation degree, and capable of providing an effective analysis method for controlling the product quality.

Description

technical field [0001] The invention relates to a method for detecting related substances in eribulin and preparations containing eribulin, belonging to the field of drug analysis and detection. Background technique [0002] Eribulin (chemical name: Eribulin, trade name: Halaven), the chemical structural formula is as follows: [0003] [0004] In November 2010, it was approved by the US FDA for the treatment of metastatic breast cancer. It was the first drug approved for liposarcoma and proved to improve survival. Eribulin’s anti-cancer mechanism is similar to that of paclitaxel. It can block the G2 / M cell circuit through the anti-mitotic pathway of tubulin and affect the mitotic spindle without affecting the shortening period of microtubules and the division of tubulin into non- secreted aggregates, and finally the mitotic process is blocked, leading to cell death. It is now used clinically for the treatment of liposarcoma (a specific form of soft tissue sarcoma) that...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89G01N30/34G01N30/74
CPCG01N30/34G01N30/74G01N30/89
Inventor 付丙月张雯王金虎张宁孙玲孙青王颖超吴伟山
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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