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High performance liquid chromatography (HPLC) method for analyzing and separating optical isomer of pantoprazole sodium

A technology for analysis and separation of pantoprazole sodium, applied in the field of analysis and separation of optical isomers of pantoprazole sodium, can solve the problems of high cost, complicated operation, large test workload, etc. sexual effect

Inactive Publication Date: 2011-08-03
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the preparation of the mobile phase is cumbersome, the pretreatment steps of the test product are also too complicated, the related test workload is relatively large, and the analysis time is also long. The retention time of the enantiomer is about 19-26 minutes, resulting in serious peak broadening.
[0010] In a word, the above methods either take a long time for analysis, or cannot achieve baseline separation of the enantiomers of pantoprazole sodium, and all of them have problems such as cumbersome operation and high cost.

Method used

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  • High performance liquid chromatography (HPLC) method for analyzing and separating optical isomer of pantoprazole sodium
  • High performance liquid chromatography (HPLC) method for analyzing and separating optical isomer of pantoprazole sodium
  • High performance liquid chromatography (HPLC) method for analyzing and separating optical isomer of pantoprazole sodium

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Instruments and Conditions

[0056] Agilent 1100 high performance liquid chromatograph;

[0057] Chromatographic column: OD-RH (Chiralcel, 150mm×4.6mm, 5μm) cellulose 3,5-dimethylphenylcarbamate chiral column;

[0058] Mobile phase volume ratio: water: acetonitrile = 75: 25;

[0059] Detection wavelength: 292nm;

[0060] Flow rate: 0.8ml / min;

[0061] Injection volume: 10 μl.

[0062] Experimental procedure

[0063] Take by weighing about 10 mg of pantoprazole sodium racemate, place in 25ml volumetric flask, add mobile phase to dissolve and be diluted to scale, shake up, as need testing solution; Each about 10 mg of isomer R-pantoprazole sodium and S-pantoprazole sodium was placed in two 25ml volumetric flasks respectively, dissolved in mobile phase and diluted to the mark, shaken up, as a qualitative control solution.

[0064] Get R-pantoprazole sodium and S-pantoprazole sodium qualitative contrast solution, carry out high performance liquid chromatography analys...

Embodiment 2

[0067] Instruments and Conditions

[0068] Agilent 1100 high performance liquid chromatograph;

[0069] Chromatographic column: OD-RH (Chiralcel, 150mm×4.6mm, 5μm) cellulose 3,5-dimethylphenylcarbamate chiral column;

[0070] Mobile phase volume ratio: disodium hydrogen phosphate / sodium dihydrogen phosphate buffer solution: mixed solvent (water: acetonitrile = 77: 23) = 0.5: 99.5;

[0071] Detection wavelength: 292nm;

[0072] Flow rate: 0.8ml / min;

[0073] Injection volume: 10 μl.

[0074] Experimental procedure

[0075] Take 1.12 g of disodium hydrogen phosphate and 0.19 g of sodium dihydrogen phosphate, add water to dissolve into 1000 ml, and adjust the pH value to 7.6 with 8% sodium hydroxide solution.

[0076] Take by weighing about 10 mg of pantoprazole sodium racemate, place in 25ml volumetric flask, add mobile phase to dissolve and be diluted to scale, shake up, as need testing solution; Each about 10 mg of isomer R-pantoprazole sodium and S-pantoprazole sodium w...

Embodiment 3

[0080] Instruments and Conditions

[0081] Instruments and Conditions

[0082] Agilent 1100 high performance liquid chromatograph;

[0083] Chromatographic column: OD-RH (Chiralcel, 150mm×4.6mm, 5μm) cellulose 3,5-dimethylphenylcarbamate chiral column;

[0084] Mobile phase volume ratio: water: acetonitrile = 77: 23;

[0085] Detection wavelength: 292nm;

[0086] Flow rate: 0.9ml / min;

[0087] Injection volume: 10 μl.

[0088] Experimental procedure

[0089] Take by weighing about 10 mg of pantoprazole sodium racemate, place in 25ml volumetric flask, add mobile phase to dissolve and be diluted to scale, shake up, as need testing solution; Each about 10 mg of isomer R-pantoprazole sodium and S-pantoprazole sodium was placed in two 25ml volumetric flasks respectively, dissolved in mobile phase and diluted to the mark, shaken up, as a qualitative control solution.

[0090] Take the above solutions, carry out high-performance liquid chromatography analysis according to the ...

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Abstract

The invention relates to a high performance liquid chromatography (HPLC) method for analyzing and separating an optical isomer of pantoprazole sodium. Cellulose 3,5-dimethyl phenyl carbamate chiral column OD-RH (Chiralcel, 150mm*4.6mm, 5 microns) is used, and a mixed solvent of water-acetonitrile in certain proportion is used as a mobile phase for separating and analyzing the optical isomer of the pantoprazole sodium.

Description

technical field [0001] The present invention relates to a kind of high performance liquid chromatography, especially a kind of high performance liquid chromatography for analyzing and separating the optical isomers of pantoprazole sodium. Background technique [0002] Substituted 2-(2-pyridylmethyl)sulfinyl-1H-benzimidazole derivatives are well known gastric proton pump inhibitors, these benzimidazole derivatives include omeprazole, pantoprazole, lanzo Larazole and Rabeprazole etc. They have the same function of inhibiting gastric acid secretion, so they are often used as anti-ulcer agents. Such as for the treatment of peptic ulcer (gastric ulcer, duodenal ulcer, anastomotic ulcer, etc.) Wherein, pantoprazole is all stable than omeprazole and lansoprazole under weakly acidic environment, and its bioavailability improves 7 times than omeprazole, and the selectivity to gastric parietal cell is high; Its antiulcer The effect is similar to omeprazole, but the interaction with...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/60
Inventor 何达陈巍储结根周斌孙田江张玉斌张贤斌尹必喜
Owner YANGTZE RIVER PHARM GRP CO LTD
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