Method for determining content and associated substances of sorafenib tosylate in high-performance liquid phase chromatography
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A technology of high performance liquid chromatography and toluenesulfonic acid, applied in the field of pharmaceutical analysis, can solve the problems of inability to achieve separation and effective control
Inactive Publication Date: 2015-12-23
JIANGSU SINOBIOPHARMA
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However, for some other known impurities of sorafenib tosy...
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Embodiment 1
[0027] The specific operation steps of HPLC assay Sorafenib tosylate content are as follows:
[0028] (1) Select 14mg of sorafenib tosylate, weigh it accurately, place it in a 100ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution;
[0029] (2) Take another 14 mg of sorafenib tosylate, and prepare it so that the concentration of sorafenib is 0.1 mg / ml, as a control solution;
[0030] (3) Take 10 μl of the test solution and the control solution respectively, inject them into the chromatograph, record the chromatogram, calculate the peak area according to the external standard method and fold it to dryness.
Embodiment 2
[0032] The specific operation steps of high-performance liquid chromatography determination sorafenib tosylate related substances are as follows:
[0033] (4) Take 14mg of sorafenib tosylate, accurately weigh it, place it in a 10ml measuring bottle, add a mixed solvent, the mixed solvent is a mixture of water, acetonitrile and ethanol, and the mixture of water, acetonitrile and ethanol The volume ratio is 250:450:300, by ultrasound, sorafenib tosylate is fully dissolved, shaken up, as the test solution;
[0034] (5) Accurately measure 1ml of the test solution, place it in a 100ml measuring bottle, dilute to the mark with the mixed solvent in step (4), and shake well; then precisely measure 1ml of the solution obtained in the first stage of step (5) , placed in a 10ml measuring bottle, dilute to the mark with the mixed solvent in step (4), shake well, and use it as a control solution;
[0035] (6) Take 10 μl of the control solution and inject it into the liquid chromatograph, ...
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Abstract
The invention discloses a method for determining content and associated substances of sorafenib tosylate. The method comprises the following steps: taking a reverse high-performance liquid phase chromatography, preparing a test solution and a reference solution, respectively measuring 10 micro liters of the test solution and 10 micro liters of reference solution, injecting the solution into a chromatograph, recording a chromatogram, calculating at a peak area according to an external standard method, and drying to complete the test on the content of the sorafenib tosylate and other substances. The method has the advantages that the blank that no method for testing and analyzing the content and associated substances of the sorafenib tosylate is provided at present is filled, the sorafenib tosylate and impurities can be separated by virtue of an acetonitrile-trifluoroacetic acid aqueous solution, the research development and production requirement can be met, and the associated substances in a sorafenib tosylate active ingredient can be more strictly and effectively controlled.
Description
technical field [0001] The invention relates to the field of drug analysis, in particular to a method for measuring the content of sorafenib tosylate and related substances by high performance liquid chromatography. Background technique [0002] Sorafenib tosylate, English name SorafenibTosylate; Sorafenib is a multi-kinase inhibitor with dual anti-tumor activity, which can inhibit tumor proliferation and angiogenesis. In preclinical studies of human tumor transplantation animal models (including: hepatocellular carcinoma, renal cancer, breast cancer, colon cancer, pancreatic cancer and lung cancer models), Sorafenib exhibited a wide range of anti-tumor activities and induced tumor cell apoptosis. effectively inhibit tumor growth. Sorafenib Tosylate Tablets is a new type of anticancer drug developed by Bayer AG in Germany. It was first approved for marketing in the United States on December 20, 2005. It has been approved in more than 50 countries in the world for the treatm...
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