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HPLC (High Performance Liquid Chromatography) method for separating naftopidil and enantiomer thereof

A nafidil, volume ratio technology, applied in the field of drug analysis, can solve the problems of manufacturing cost, high sales price, short service life and the like, and achieve the effects of short separation time and reduced separation cost

Active Publication Date: 2021-04-06
江苏和汇医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The AD-H chiral column and Chiralpak AD-RH chiral column used in the above literature are all chiral chromatographic columns specially used for the separation of chiral compounds. Columns are much shorter

Method used

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  • HPLC (High Performance Liquid Chromatography) method for separating naftopidil and enantiomer thereof
  • HPLC (High Performance Liquid Chromatography) method for separating naftopidil and enantiomer thereof
  • HPLC (High Performance Liquid Chromatography) method for separating naftopidil and enantiomer thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021]: 1. Instruments and testics

[0022]1, instrument

[0023]US Agilent 1260 Liquid Chromatograph (vacuum degassing, binary pump, automatic injection).

[0024]Columns: Waters Xbridge C18 column (4.6mm × 150 mm, 5 μm).

[0025]Mettler toledo Electronic Balance (XS105).

[0026]2, reagent

[0027](R) - Napperinini - Part (S) - The purity of the napiulin diolis is not less than 99%, and the structural formula isfigure 1 Indicated.

[0028]Chiral additive FMOC-N-methyl-L-isoleucine is purchased from the microplin reagent, purity 98%.

[0029]Acetonitrile, methanol is pure, water is ultrapure.

[0030]Second, methods and results

[0031]1, chromatographic conditions

[0032]Column: Waters Xbridge C18 column (4.6mm × 150mm, 5 μm);

[0033]Mobile phase A phase: a 5% aqueous methanol solution containing 0.05 mol / lfmoc-N-methyl-L-isoleucine (formulated method: first mix methanol and water in volume ratio 5:95, then add chiral additive Formulated into desired concentrations);

[0034]Mobile phase B phase: acetonitrile and m...

Embodiment 2

[0046]Example 2: Comparative Example, Mobile Phase does not add a chiral additive

[0047]First, instrument and test

[0048]1, instrument

[0049]US Agilent 1260 Liquid Chromatograph (vacuum degassing, binary pump, automatic injection).

[0050]Columns: Waters Xbridge C18 column (4.6mm × 150 mm, 5 μm).

[0051]Mettler toledo Electronic Balance (XS105).

[0052]2, reagent

[0053](R) - Napperinini - Part (S) - The purity of the napiulin diolis is not less than 99%, and the structural formula isfigure 1 Indicated.

[0054]Acetonitrile, methanol is pure, water is ultrapure.

[0055]Second, methods and results

[0056]1, chromatographic conditions

[0057]Column: Waters Xbridge C18 column (4.6mm × 150mm, 5 μm);

[0058]Mobile phase A phase: 5% methanol aqueous solution (preparation method: mixed methanol and water in volume ratio 5:95);

[0059]Mobile phase B phase: acetonitrile and methanol are mixed with a mixed organic solvent formed by volume ratio 4: 3;

[0060]Elip mode and scale: A phase and B phase elute according to v...

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Abstract

The invention discloses an HPLC (High Performance Liquid Chromatography) method for separating naftopidil and an enantiomer thereof. The naftopidil has a chiral center and a pair of enantiomers (R) naftopidil and (S) naftopidil. An active ingredient for clinical use is (R) naftopidil. In order to control the purity of (R) naftopidil, it is necessary to establish an analytical method capable of separating (R) naftopidil from (S) naftopidil. At present, a chiral chromatographic column is used for separating the two compounds so that the cost is high. According to the HPLC method provided by the invention, based on a cheap C18 chromatographic column as a separation means, (R) naftopidil and (S) naftopidil are effectively separated, the separation time is relatively short, and the separation cost of naftopidil and enantiomers thereof can be greatly reduced.

Description

Technical field[0001]The present invention belongs to the field of drug analysis, and more particularly to an HPLC method for separating napiulinin and its enantiomer.Background technique[0002]Naftopidil is chemically named 1- (2-methoxy) -4- [3- (1-naphthoxy) -2-hydroxypropyl] -piperazine, is from Japanese clock A new type of receptor antagonist developed by Xucheng into pharmaceutical Co., Ltd., which is the first time to listed in Japan in June 1999, for the treatment of diseases such as prostatic hyperplasia.[0003]There is a chiral center with a pair of enantiomers, and the chemical structure is shown below:[0004][0005]The active ingredient (R) -ninolite was used in clinical use. In order to control (R)--napiulin purity, it is necessary to establish an analytical method that can be separated by (R)-napromell and (s)-napiulinin.[0006]YINXIANG SUN et al. Established a chiral high-performance liquid chromatography to determine the method of unnecodent enantioma, using a chromatogra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/74G01N30/88
CPCG01N30/02G01N30/34G01N30/74G01N30/88G01N2030/8877G01N2030/884Y02P20/55
Inventor 不公告发明人
Owner 江苏和汇医药科技有限公司
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