Check patentability & draft patents in minutes with Patsnap Eureka AI!

Method for detecting related substances of mesylate lenvatinib

A technology of lenvatinib and related substances, which is applied in the field of detection of related substances of lenvatinib mesylate, can solve problems such as impurity peak splitting, affecting analysis accuracy, known impurity peak splitting, etc., to avoid potential safety hazards , control product quality, good separation effect

Pending Publication Date: 2021-10-22
SIMCERE ZAIMING PHARM CO LTD
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The detection method for related substances of lenvatinib mesylate in the prior art has the problem of peak splitting of some known impurities, which leads to the inability to quantify the impurities and affects the accuracy of the analysis
However, there is no other analytical method recorded in the prior art that can effectively solve the problem of impurity split peaks

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for detecting related substances of mesylate lenvatinib
  • Method for detecting related substances of mesylate lenvatinib
  • Method for detecting related substances of mesylate lenvatinib

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 1) Chromatographic conditions:

[0051] Instrument: Agilent1260 HPLC

[0052] Chromatographic column: Octadecylsilane bonded silica gel column (YMC pack pro C 18 , 75×4.6mm, 3μm)

[0053] Mobile phase A: a mixed solution of acetonitrile, water and perchloric acid, the volume ratio of the three is 10:990:1

[0054] Mobile phase B: a mixed solution of acetonitrile, water and perchloric acid, the volume ratio of the three is 900:100:1

[0055] Gradient elution as follows:

[0056] time (min) Mobile phase A% Mobile phase B% 0 100 0 22 55 45 25 55 45 25.01 100 0 30 100 0

[0057] Column temperature: 35°C

[0058] Flow rate: 1.5ml / min

[0059] Detection wavelength: 252nm

[0060] Injection volume: 10μl

[0061] Solvent: a mixed solution of methanol and water containing 1% (ratio to the total volume of methanol and water) triethylamine, wherein the volume ratio of methanol and water is 80:20.

[0062] 2) Sample preparati...

Embodiment 2

[0067] 1) Chromatographic conditions:

[0068] Instrument: Agilent1260 HPLC

[0069] Chromatographic column: Octadecylsilane bonded silica gel column (YMC pack pro C 18 , 75×4.6mm, 3μm)

[0070] Mobile phase A: a mixed solution of acetonitrile, water and trifluoroacetic acid (the volume ratio of the three is 10:990:1)

[0071] Mobile phase B: a mixed solution of acetonitrile, water and trifluoroacetic acid (the volume ratio of the three is 900:100:1)

[0072] Gradient elution as follows:

[0073] time (min) Mobile phase A% Mobile phase B% 0 100 0 22 55 45 25 55 45 25.01 100 0 30 100 0

[0074] Column temperature: 35°C

[0075] Flow rate: 1.5ml / min

[0076] Detection wavelength: 255nm

[0077] Injection volume: 10μl

[0078] Solvent: a mixed solution of methanol and water containing 0.8% (ratio to the total volume of methanol and water) of triethylamine, wherein the volume ratio of methanol and water is 80:20

[0079] 2) ...

Embodiment 3

[0084] 1) Chromatographic conditions:

[0085] Instrument: Agilent1260 HPLC

[0086] Chromatographic column: Octadecylsilane bonded silica gel column (YMC pack pro C 18 , 75×4.6mm, 3μm)

[0087] Mobile phase A: a mixed solution of acetonitrile, water, trifluoroacetic acid, and triethylamine (the volume ratio of the four is 10:990:5:1)

[0088] Mobile phase B: a mixed solution of acetonitrile, water, trifluoroacetic acid, and triethylamine (the volume ratio of the four is 900:100:1:0.5)

[0089] Gradient elution as follows:

[0090] time (min) Mobile phase A% Mobile phase B% 0 100 0 22 55 45 25 55 45 25.01 100 0 30 100 0

[0091] Column temperature: 35°C

[0092] Flow rate: 1.6ml / min

[0093] Detection wavelength: 245nm

[0094] Injection volume: 10μl

[0095] Solvent: a mixed solution of methanol and water, the volume ratio of the two is 80:20

[0096] 2) Sample preparation:

[0097] Take an appropriate amount of lenvat...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
wavelengthaaaaaaaaaa
wavelengthaaaaaaaaaa
wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention discloses a method for detecting related substances of lenvatinib mesylate. The method comprises the following steps of: 1) sample preparation, specifically, taking a lenvatinib mesylate bulk drug or preparation, and dissolving the lenvatinib mesylate bulk drug or preparation with a solvent to prepare a test solution containing lenvatinib mesylate; and 2) detection, specifically, measuring the test solution, injecting the test solution into a high performance liquid chromatograph, carrying out gradient elution by adopting double mobile phases, and recording a chromatogram. The solvent in the step 1) contains triethylamine, and / or at least one mobile phase and / or two mobile phases in the double mobile phases in the step 2) contain triethylamine. By using the related substance detection method provided by the invention, the peak pattern of the known impurity of the product is obviously improved, and the impurity can be accurately quantified, so that the accuracy of analyzing the impurity in a mesylate lenvatinib sample is improved.

Description

technical field [0001] The invention relates to a method for detecting related substances, in particular to a method for detecting related substances of lenvatinib mesylate. Background technique [0002] Lenvatinib mesylate was developed by Eisai Pharmaceutical Co., Ltd., Japan. It is an oral multi-receptor tyrosine kinase (RTK) inhibitor. Approved for marketing and approved by the European Union in June 2015 for progressive, locally advanced or metastatic radioactive iodine refractory (RAI) differentiated (papillary / follicular / eosinophilic) thyroid cancer (DTC) and liver cancer treatment of patients. [0003] The detection method for related substances of lenvatinib mesylate in the prior art has the problem of split peaks of some known impurities, which leads to the inability to quantify the impurities and affects the accuracy of the analysis. However, there is no other analytical method recorded in the prior art that can effectively solve the problem of impurity peak spl...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/86
CPCG01N30/02G01N30/34G01N30/8679
Inventor 王霞夏园园穆晓燕任晋生
Owner SIMCERE ZAIMING PHARM CO LTD
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com