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Separating measuring method for otioxetine hydrobromide end product related substances

A technology of vortioxetine hydrobromide and its determination method, which is applied in the field of analytical chemistry, can solve problems such as endangering human health, having no therapeutic effect, affecting drug stability and curative effect, and achieving the effect of ensuring quality

Inactive Publication Date: 2019-03-26
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All of the above-mentioned related substances have no therapeutic effect, and may also affect the stability and curative effect of the drug, and even endanger human health. There are 9 related substances mainly controlled for the synthesis of vortioxetine hydrobromide, which are respectively: related substances 1, 1 -Bromo-2-(2,4-Dimethyl-phenylsulfanyl)-benzene; Related substance 2: 2,4-Dimethyl-benzonethiol; Related substance 3: 1-Bromo-2-iodo-benzene; Related substance 4: Di(2 ,4)-xyly)disulphide; related substance 5: 1-[2-(2,4-Dimethyl-phenylsulfinyl)-phenyl]-piperazine; related substance 6: 2-(2,4-Dimethyl-phenylsulfanyl)-nitrobenzene; Related substance 7: 2,4-Dimethyl-1-phenylsulfanyl-benzene; Related substance 8: Toluene; Related substance 9: 2,2′-bis-diphenylphosphanyl-[1,1′]binaphtalencyl

Method used

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  • Separating measuring method for otioxetine hydrobromide end product related substances
  • Separating measuring method for otioxetine hydrobromide end product related substances
  • Separating measuring method for otioxetine hydrobromide end product related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Instruments and Conditions

[0043] Shimadzu HPLC: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0044] Chromatographic column: C8 (Alltima, 250×4.6mm, 5μm)

[0045] Mobile phase: A phase: 0.05mol / L ammonium acetate buffer solution (pH 4.0); B phase: acetonitrile

[0046] Elution gradient:

[0047]

[0048] Flow rate: 1.0mL / min

[0049] Detection wavelength: 220nm

[0050] Column temperature: 30°C

[0051] Injection volume: 10μL

[0052] Experimental procedure

[0053] Take an appropriate amount of vortioxetine hydrobromide, dissolve the sample with acetonitrile, and prepare a solution containing about 0.5 mg / mL of vortioxetine hydrobromide; Dissolve and prepare an impurity mixed solution containing about 0.5 mg / ml of each impurity; take an appropriate amount of the impurity mixed solution and vortioxetine hydrobromide solution to prepare a system suitability solution. Perform HPLC analysis according to the above conditions, and record the chromatograms...

Embodiment 2

[0055] Instruments and Conditions

[0056] Shimadzu HPLC: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0057] Chromatographic column: C8 (Alltima, 250×4.6mm, 5μm)

[0058] Mobile phase: A phase: 0.05mol / L sodium perchlorate buffer solution (pH 4.0); B phase: acetonitrile

[0059] Elution gradient:

[0060]

[0061] Flow rate: 1.0mL / min

[0062] Detection wavelength: 220nm

[0063] Column temperature: 30°C

[0064] Injection volume: 10μL

[0065] Experimental procedure

[0066] Take an appropriate amount of vortioxetine hydrobromide, dissolve the sample with acetonitrile, and prepare a solution containing about 0.5 mg / mL of vortioxetine hydrobromide; , to prepare an impurity mixed solution containing about 0.5 mg / ml of each impurity; take an appropriate amount of the impurity mixed solution and vortioxetine hydrobromide solution to prepare a system suitability solution. Perform HPLC analysis according to the above conditions, and record the chromatograms. see a...

Embodiment 3

[0068] Instruments and Conditions

[0069] Shimadzu HPLC: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0070] Chromatographic column: C8 (Alltima, 250×4.6mm, 5μm)

[0071] Mobile phase: A phase: 0.05mol / L sodium perchlorate buffer solution (pH 4.0); B phase: acetonitrile

[0072] Elution gradient:

[0073]

[0074] Flow rate: 1.0mL / min

[0075] Detection wavelength: 220nm

[0076] Column temperature: 30°C

[0077] Injection volume: 10μL

[0078] Experimental procedure

[0079] Take an appropriate amount of vortioxetine hydrobromide, dissolve the sample with acetonitrile, and prepare a solution containing about 0.5 mg / mL of vortioxetine hydrobromide; , to prepare an impurity mixed solution containing about 0.5 mg / ml of each impurity; take an appropriate amount of the impurity mixed solution and vortioxetine hydrobromide solution, and prepare a system suitability solution; additionally take acetonitrile as a blank solvent. Perform HPLC analysis according to the...

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Abstract

The invention belongs to the field of analytical chemistry and discloses a method of separating and measuring otioxetine hydrobromide and related substances thereof by liquid chromatography. The method can measure the contents of otioxetine hydrobromide and related substances thereof quantitively by taking an octyl alkyl silane bonded silica gel as a chromatographic column of filler and a buffer salt solution-organic phase in a certain proportion as a moving phase, so that the quality of the otioxetine hydrobromide is controlled effectively. The method is high in specificity, high in accuracyand simple to operate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring vortioxetine hydrobromide and its related substances by liquid chromatography. Background technique [0002] Vortioxetine hydrobromide can inhibit the reuptake of serotonin, and has the functions of 5-HT1A receptor agonist, 5-HT1B receptor partial agonist and 5-HT3, 5-HT1D and 5-HT7 receptor antagonist. in the treatment of major depressive disorder. The English name is Vortioxetine Hydrobromide, the chemical name is 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide, and the molecular formula is C 18 h 22 N 2 S. HBr. The structural formula of vortioxetine hydrobromide is: [0003] . [0004] In the process of synthesizing vortioxetine hydrobromide, there are several important starting materials and intermediates that may affect the purity of the drug due to incomplete removal. These impurities that affect the purit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 贾少华王宇杰
Owner 万全万特制药(厦门)有限公司
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