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A kind of HPLC method analyzes the method for separation dorzolamide hydrochloride enantiomer

A technology for dorzolamide hydrochloride and enantiomers, which is applied in the field of high-performance liquid chromatography to analyze and separate drugs, can solve unseen problems, and achieve the effects of ensuring stability, ensuring quality control, and improving symmetry

Active Publication Date: 2016-09-28
南京奥罗生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The separation of optical isomers containing chiral carbon atoms has always been a difficult point in quality control during the synthesis and preparation of chiral drugs. After searching the literature, there is no report on the detection method of (-) trans dorzolamide hydrochloride optical isomers

Method used

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  • A kind of HPLC method analyzes the method for separation dorzolamide hydrochloride enantiomer
  • A kind of HPLC method analyzes the method for separation dorzolamide hydrochloride enantiomer
  • A kind of HPLC method analyzes the method for separation dorzolamide hydrochloride enantiomer

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Instruments and Conditions

[0032] Chromatographic column: AD-H (Daicel, 250mm×4.6mm, 5μm);

[0033] Mobile phase: n-hexane-absolute ethanol-diethylamine=84:16:0.02;

[0034] Column temperature: 30°C;

[0035] Flow rate: 1.0ml / min;

[0036] Injection volume: 10μl;

[0037] Detection wavelength: 254nm;

[0038] Experimental procedure

[0039] Weigh an appropriate amount of dorzolamide hydrochloride trans-racemate, add methanol to dissolve and dilute, and make a solution containing about 10 μg per 1 ml, as a system suitability solution. Take (-) trans dorzolamide hydrochloride 10mg, accurately weighed, put in a 10ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, as the test solution. Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with methanol to make a solution containing 5 μg per 1 ml, as a control solution. Measure 10 μl of the system suitability solution, inject it into a liquid chroma...

Embodiment 2

[0042] Instruments and Conditions

[0043] Chromatographic column: AD-H (Daicel, 250mm×4.6mm, 5μm);

[0044] Mobile phase: n-hexane-absolute ethanol-diethylamine=80:20:0.02;

[0045] Column temperature: 30°C;

[0046] Flow rate: 1.0ml / min;

[0047] Injection volume: 10μl;

[0048] Detection wavelength: 254nm;

[0049] Experimental procedure

[0050] Weigh an appropriate amount of dorzolamide hydrochloride trans-racemate, add methanol to dissolve and dilute, and make a solution containing about 10 μg per 1 ml, as a system suitability solution. Take (-) trans dorzolamide hydrochloride 10mg, accurately weighed, put in a 10ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, as the test solution. Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with methanol to make a solution containing 5 μg per 1 ml, as a control solution. Measure 10 μl of the system suitability solution, inject it into a liquid chroma...

Embodiment 3

[0053] Instruments and Conditions

[0054] Chromatographic column: AD-H (Daicel, 250mm×4.6mm, 5μm);

[0055] Mobile phase: n-hexane-absolute ethanol-diethylamine=86:14:0.02;

[0056] Column temperature: 30°C;

[0057] Flow rate: 1.0ml / min;

[0058] Injection volume: 10μl;

[0059] Detection wavelength: 254nm;

[0060] Experimental procedure

[0061]Weigh an appropriate amount of dorzolamide hydrochloride trans-racemate, add methanol to dissolve and dilute, and make a solution containing about 10 μg per 1 ml, as a system suitability solution. Take (-) trans dorzolamide hydrochloride 10mg, accurately weighed, put in a 10ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, as the test solution. Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with methanol to make a solution containing 5 μg per 1 ml, as a control solution. Measure 10 μl of the system suitability solution, inject it into a liquid chromat...

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Abstract

The invention discloses a method for analyzing and separating dorzolomide hydrochloride enantiomers by an HPLC (high performance liquid chromatography) process. According to the method, the dorzolomide hydrochloride enantiomers are separated through the normal-phase chromatography process taking a normal-phase mixed solvent as a flowing phase by a cellulose chiral column. Through the method, the dorzolomide hydrochloride enantiomers can be quickly separated and analyzed.

Description

technical field [0001] The invention relates to a method for analyzing and separating drugs by high performance liquid chromatography, in particular to a high performance liquid chromatography for analyzing and separating dorzolamide hydrochloride and its optical isomers. Background technique [0002] Dorzolamide is a carbonic anhydrase inhibitor. Dorzolamide hydrochloride is used to reduce increased intraocular pressure in open-angle glaucoma and ocular hypertension. Its molecular formula is C 10 h 16 N 2 o 4 S 3 HCl, chemical name (4S,6S)-6-methyl-4-ethylamino-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfamoyl 7,7 -dioxide hydrochloride, structural formula is: [0003] [0004] The molecule contains 2 chiral centers and 4 optical isomers. In this synthetic route, the diastereomer dorzolamide cis racemate exists as an impurity in the dorzolamide trans racemate The amount is very small, and the enantiomer (-)(4S,6S)-6-methyl-4-ethylamino-5,6-dihydro-4H-thieno[2 ,3...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 沈婕乔春莲朱墨周静杨波
Owner 南京奥罗生物科技有限公司
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