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HPLC method for separating and analyzing voriconazole prodrug related substances

A technology for voriconazole and related substances, which is applied in the field of high performance liquid phase analysis and can solve problems such as difficulty in effective separation

Active Publication Date: 2016-06-22
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0033] From the structural investigation of the above impurities, some impurities are very similar in structure to voriconazole phosphate or its medicinal salt, and from the perspective of polarity, some impurities have a great difference in polarity from voriconazole phosphate or its medicinal salt; Therefore, it is very difficult to completely and effectively separate the above-mentioned impurities under the same chromatographic condition, which makes it necessary to find a chromatographic condition that not only requires the effective separation of similar structure impurities but also takes into account the effective detection of weak polar impurities.

Method used

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  • HPLC method for separating and analyzing voriconazole prodrug related substances
  • HPLC method for separating and analyzing voriconazole prodrug related substances
  • HPLC method for separating and analyzing voriconazole prodrug related substances

Examples

Experimental program
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Effect test

Embodiment 1

[0056] Experimental equipment and conditions

[0057] High performance liquid chromatography: Thermo high performance liquid chromatography Ultimate3000;

[0058] Chromatographic column: C18150×4.6mm5μm;

[0059] Mobile phase: acetonitrile: buffer (take 0.606g of sodium heptanesulfonate and 6.80g of potassium dihydrogen phosphate into 1000ml of water, stir to dissolve, adjust the pH to 3.00 with phosphoric acid) = 20:80;

[0060] Flow rate 1.0ml / min;

[0061] Detection wavelength: 256nm;

[0062] Column temperature 20°C;

[0063] The injection volume was 10 μl.

[0064]Get voriconazole phosphate or its medicinal salt and the above-mentioned impurities, dissolve and dilute with a suitable medium to make the test solution and the impurity solution, get each 10 μl of the test solution and the impurity solution, inject into the high performance liquid chromatograph, the results are as follows:

[0065] sample Retention time (min) Separation Impurity I 4.83...

Embodiment 2

[0068] Experimental equipment and conditions

[0069] High performance liquid chromatography: Thermo high performance liquid chromatography Ultimate3000;

[0070] Chromatographic column: C18150×4.6mm5μm;

[0071] Mobile phase: Phase A: buffer solution (take 0.606g of sodium heptanesulfonate and 6.80g of potassium dihydrogen phosphate into 1000ml of water, stir to dissolve, adjust the pH to 3.00 with phosphoric acid); phase B: acetonitrile; the gradient conditions are as follows:

[0072] time (min) Phase A (%) Phase B (%) 0 80 20 15 80 20 45 50 50 50 82 18 60 82 18

[0073] Flow rate 1.0ml / min;

[0074] Detection wavelength: 256nm;

[0075] Column temperature 25°C;

[0076] The injection volume was 10 μl.

[0077] Get voriconazole phosphate or its medicinal salt and the above-mentioned impurities, dissolve and dilute with a suitable medium to make the test solution and the impurity solution, get each 10 μl of the test solut...

Embodiment 3

[0081] Experimental equipment and conditions

[0082] High performance liquid chromatography: Thermo high performance liquid chromatography Ultimate3000;

[0083] Chromatographic column: phenyl column 250×4.6mm5μm;

[0084] Mobile phase: Phase A: buffer solution (take 0.606g of sodium heptanesulfonate and 6.80g of potassium dihydrogen phosphate into 1000ml of water, stir to dissolve, adjust the pH to 3.00 with phosphoric acid); phase B: acetonitrile; the gradient conditions are as follows:

[0085] time (min) Phase A (%) Phase B (%) 0 82 18 15 82 18 45 50 50 50 82 18 60 82 18

[0086] Flow rate 1.0ml / min;

[0087] Detection wavelength: 256nm;

[0088] Column temperature 25°C;

[0089] The injection volume was 10 μl.

[0090] Get voriconazole phosphate or its medicinal salt and the above-mentioned impurities, dissolve and dilute with a suitable medium to make the test solution and the impurity solution, get each 10 μl of the t...

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Abstract

The method discloses an HPLC method for separating and analyzing related substances of voriconazole prodrug. High performance liquid chromatography is adopted, C18, phenyl column, and cyano column are used as chromatographic columns, buffer solution (pH value 2-9) and organic solvent The mobile phase is composed in a certain proportion, and the method can quickly, effectively and accurately separate and analyze related substances of voriconazole phosphate or its medicinal salt.

Description

technical field [0001] The invention relates to a high-efficiency liquid phase analysis method, in particular to the separation, analysis and determination of related substances of voriconazole phosphate or its medicinal salt. Background technique [0002] Voriconazole phosphate or its pharmaceutically acceptable salt is the prodrug of voriconazole, voriconazole phosphate or its pharmaceutically acceptable salt enters the body and can be metabolized into voriconazole through the action of alkaline phosphatase, thus exerting its medicinal effect. Voriconazole is a broad-spectrum triazole antifungal agent indicated for the following: treatment of invasive aspergillosis, treatment of severe invasive infections caused by fluconazole-resistant Candida species (including Candida krusei), treatment of Serious infections caused by Actinomycetes and Fusarium spp. This product should be used primarily for the treatment of progressive, potentially life-threatening infections in immunoc...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/62G01N30/06
Inventor 张起愿罗二云张丽芳
Owner HC SYNTHETIC PHARMA CO LTD
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