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Content determining and related substance detection method for tofacitinib citrate

A technology of tofacitinib and related substances, which is applied in the field of drug analysis, can solve the problems of the content of raw materials and the analysis methods of related substances without literature reports, etc., and achieve good repeatability and recovery, accurate content determination results, and high precision Effect

Active Publication Date: 2015-03-25
NANJING CORE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows for precise identification or quantitation of certain compounds found within taficimab (tofibrate) that are involved with treatments like rheuma-related diseases such as lupus erythematosus by measuring their concentration levels during immunotherapy procedures. By analyzing these concentrations over time, we aimed at identifying new drugs targeting specific molecules associated therewith. Additionally, this technology could help identify any other chemicals added through various routes into pharmaceutical products meant to fight against inflammatory processes caused by bacterial attacks on joint cartilage cells called chondrocytes. Overall, our discovery process provides valuable data about drug candidates' properties and potential uses thereover.

Problems solved by technology

This patented technical problem addressed in this patents relates to studying and analyzing the contents of certain ingredients used during different stages of treatments involving specific diseases like relapses multiple sclerosis syndrome caused by rhenocytomia adverse reaction associated with immunosuppressants commonly prescribed drugs including steroids/stabilizers, calcimimetic agents, cyclophosphazepines, sulfonic acid amides, carbapenems, tripodponide, etc.. These chemical products contain impurity metals and organics derived from these medicinal components.

Method used

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  • Content determining and related substance detection method for tofacitinib citrate
  • Content determining and related substance detection method for tofacitinib citrate
  • Content determining and related substance detection method for tofacitinib citrate

Examples

Experimental program
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Effect test

Embodiment 1

[0019] Example 1: Determination of reversed-phase high-performance liquid chromatography of tofacitinib citrate content

[0020] Chromatographic conditions and system suitability test take octadecyl silane bond and silica gel as filler; with acetonitrile-0.05mol / L ammonium acetate (90:10) as mobile phase A, with acetonitrile-0.05mol / L ammonium acetate (10 :90) is mobile phase B; Carry out gradient elution according to the following table. The flow rate is 1.0ml per minute; the detection wavelength is 286nm. The number of theoretical plates is not less than 4000 based on the peak of tofacitinib.

[0021]

[0022] The following items of the assay method were verified:

[0023] 1. Linearity and range

[0024] Take about 10mg of tofacitinib citrate reference substance, accurately weigh it, put it in a 50ml measuring bottle, add mobile phase to ultrasonically dissolve and dilute to the mark; accurately measure 1.0, 1.5, 2.0, 2.5, 3.0ml to a 10ml measuring bottle In the solut...

Embodiment 2

[0048] Embodiment 2: Determination of related substances of tofacitinib citrate by reversed-phase high-performance liquid chromatography

[0049]Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix VD).

[0050] Chromatographic conditions and system suitability test use octadecylsilane bond and silica gel as filler; use acetonitrile-50mmol / L ammonium acetate (9:1) as mobile phase A; use acetonitrile-50mmol / L ammonium acetate (1:9 ) is the mobile phase B to carry out linear gradient elution according to the table. The flow rate is 1.0ml per minute; the detection wavelength is 286nm. Take tofacitinib citrate known impurity Ⅰ (intermediate 3), impurity Ⅱ (intermediate 2), impurity Ⅲ (starting material 2), impurity Ⅳ (intermediate 1), isomers (not enantiomer) and appropriate amount of tofacitinib citrate, add acetonitrile to ultrasonically dissolve and dilute to make each 1ml containing known impurity Ⅰ (intermediate 3), ...

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Abstract

The invention discloses a content determining and related substance detection method for tofacitinib citrate. The method is mainly used for determining and examining medicinal raw materials of tofacitinib citrate and related substances by using efficient liquid chromatography. The method disclosed by the invention is high in detection rate of the related substances, high in precision, accurate in content determining result and good in repeatability and recovery rate. The method verified can be used for routine analysis and quality control of raw materials of tofacitinib citrate and a preparation sample.

Description

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Claims

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Application Information

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Owner NANJING CORE TECH CO LTD
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