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Method for separating and measuring lurasidone hydrochloride intermediate related substances through liquid chromatography

A technology for lurasidone hydrochloride and its determination method, which is applied in the field of separation and determination of lurasidone hydrochloride intermediates and related substances by liquid chromatography, and can solve the problem of incomplete removal of impurities, side reaction impurities, and influence on drug purity and quality and other issues to achieve the effect of ensuring purity, reducing side reactions, and quality control

Inactive Publication Date: 2016-08-24
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Incomplete removal of impurities in the intermediate of lurasidone hydrochloride will cause side reactions and generation of impurities, thus affecting the purity and quality of the drug

Method used

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  • Method for separating and measuring lurasidone hydrochloride intermediate related substances through liquid chromatography
  • Method for separating and measuring lurasidone hydrochloride intermediate related substances through liquid chromatography
  • Method for separating and measuring lurasidone hydrochloride intermediate related substances through liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Instruments and Conditions

[0039] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp

[0040] Chromatographic column: C8 (Phenomenex, 250×4.6 mm, 5 μm)

[0041] Mobile phase: A: 20 mmol / L potassium dihydrogen phosphate and 10 mmol / L sodium heptanesulfonate solution (pH 6.0)

[0042] B: Acetonitrile

[0043] Flow rate: 1.0 mL / min

[0044] Detection wavelength: 230 nm

[0045] Injection volume: 10 μL

[0046] time (min) mobile phase A mobile phase B 0 70 30 12 70 30 17 58 42 27 40 60 32 70 30 50 70 30

[0047] Experimental procedure

[0048] Take an appropriate amount of lurasidone hydrochloride intermediate and its related substances, dissolve it in methanol, and prepare a solution containing 0.5 mg of lurasidone hydrochloride intermediate and its related substances per 1 mL. Take an appropriate amount of the above-mentioned lurasidone hydrochloride intermediate ...

Embodiment 2

[0050] Instruments and Conditions

[0051] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp

[0052] Chromatographic column: C8 (Phenomenex, 250×4.6 mm, 5 μm)

[0053] Mobile phase: A: 20 mmol / L potassium dihydrogen phosphate and 10 mmol / L sodium heptanesulfonate solution (pH 6.0)

[0054] B: Acetonitrile

[0055] Flow rate: 1.0 mL / min

[0056] Detection wavelength: 230 nm

[0057] Injection volume: 10 μL

[0058] time (min) mobile phase A mobile phase B 0 70 30 12 70 30 17 58 42 30 45 55 40 70 30 50 70 30

[0059] Experimental procedure

[0060] Take an appropriate amount of lurasidone hydrochloride intermediate and its related substances, dissolve it in methanol, and prepare a solution containing 0.5 mg of lurasidone hydrochloride intermediate and its related substances per 1 mL. Take an appropriate amount of the above-mentioned lurasidone hydrochloride intermediate ...

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Abstract

The invention belongs to the field of analytical chemistry and discloses a method for separating and detecting lurasidone hydrochloride intermediate 3-(1-piperazinyl)-1,2-benzisothiazole and related substances through liquid chromatography. According to the method, octyl silane bonded silica gel serves as a chromatographic column of filler, ion-pairing reagent-buffer salt solution-organic phase in a certain proportion serves as a mobile phase, and the content of the lurasidone hydrochloride intermediate and the related substances of the intermediate can be measured, so that purity of reactants in the production process of lurasidone hydrochloride is effectively controlled, side reactions and impurities are reduced, the yield of the product is increased, and the quality of the product is improved. The method is high in specificity, high in accuracy and easy and convenient to operate.

Description

Technical field [0001] The present invention is an analytical chemistry field, which involves the method of liquid chromatography separation to determine the method of Luollazone hydrochloride and its related substances. Background technique [0002] Phalisidone hydrochloride is an atypical anti -psychiatric drug that is clinically used for the treatment of schizophrenia and can improve cognitive function.The chemical name of the hydrochloride hydrochloride is (3AR, 4S, 7R, 7AS) -2-{(1R, 2R) -2- [4- (1,2-benzopyrerazole-3-base) thozide -1-Arnamyl] Huan Ji-based methyl-based} 6,7-Qiansha-2H-alien-1,3-dione hydrochloric acid salt, molecular formula is C 28 H 36 N 4 O 2 S · HCL.The intermediate body chemical name of hydrochloride hydrochloride is 3- (1-thozide) -1,2-benzopyrene, molecular formula is C 11 H 13 N 3 S, the structure formula is: [0003] [0004] In the process of synthetic hydrochloride, the purity of some important intermediates needs to be controlled to reduce the ...

Claims

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Application Information

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IPC IPC(8): G01N30/60G01N30/74G01N30/06
CPCG01N30/06G01N30/60G01N30/74
Inventor 贾少华刘秋叶
Owner BEIJING VENTUREPHARM BIOTECH
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