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A method for analyzing related substances of sunitinib malate

A technology for sunitinib malate and related substances, which is applied in the field of optimized detection of chemical raw material sunitinib malate related substances, and can solve the problems of low accuracy, poor specificity, low efficiency and the like

Inactive Publication Date: 2016-06-01
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore described method exists specificity difference, accuracy is low and operation time is too long, the problem of low efficiency

Method used

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  • A method for analyzing related substances of sunitinib malate
  • A method for analyzing related substances of sunitinib malate
  • A method for analyzing related substances of sunitinib malate

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Experimental program
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Embodiment Construction

[0025] The related substance analysis method of sunitinib malate crude drug provided by the invention is characterized in that:

[0026] The method is carried out on a high performance liquid chromatograph;

[0027] The detector is a diode array detector (DAD) or an ultraviolet absorption detector (UV), and the detection wavelength is 268nm;

[0028] The liquid chromatographic column is Poroshell120BonusRP reversed-phase chromatographic column, and the temperature of the chromatographic column is 20℃~30℃;

[0029] The mobile phase is composed of ammonium acetate aqueous solution as a buffer and acetonitrile as an organic solvent, and is subjected to gradient elution, and the flow rate of the mobile phase is about 0.9mL / min~1.1mL / min;

[0030] Inject sunitinib malate test solution and sunitinib malate reference solution for detection, and calculate the content of related substances according to the principal component self-control method without correction factor.

[0031] In...

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Abstract

The invention relates to a method for analyzing substances relevant to sunitinib malate. The method is carried out on a high performance liquid chromatography; a Poroshell120 Bonus RP chromatographic column is adopted; an ammonium acetate aqueous solution and an organic solvent-acetonitrile act as flow phases; a liquid phase diode array detector (DAD) or an ultraviolet (UV) detector are used for performing gradient elution detection; a relevant substance B, a relevant substance C, a relevant substance E and other relevant substances are separated and detected effectively. The method has the characteristics of good specificity, high accuracy, easiness, convenience and rapidness.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, and more specifically relates to an optimized method for detecting related substances of sunitinib malate, a chemical raw material drug. Background technique [0002] Sunitinib malate, chemical name N-(2-diethylaminoethyl)-5[(Z)-(5-fluoro-2-oxo-1hydro-indole-3-ylidene)methyl ]-2,4-dimethyl-1 hydrogen-pyrrole-3-carboxamide malate, its chemical structure is: [0003] [0004] It is a multi-target receptor tyrosine kinase (RTK) inhibitor, which is mainly used for the treatment of gastrointestinal stromal tumors and metastatic renal cell carcinoma that do not respond to or cannot tolerate standard therapy through oral administration. The drug has been approved for marketing by the US FDA and the European EMEA, and the product is Sutent. Chinese authorized patent CN1329390C discloses a preparation method of sunitinib malate. [0005] Usually, sunitinib malate raw materials also cont...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 杨成栾保磊刘国柱
Owner SUNSHINE LAKE PHARM CO LTD
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