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High performance liquid chromatography (HPLC) detection method for valganciclovir hydrochloride intermediate condensation product isomer

A technology of valganciclovir hydrochloride and detection method, applied in the field of drug analysis, can solve problems such as unfavorable enterprise product quality control, and achieve the effects of simple, reliable analysis and detection method and high sensitivity in research and development and production

Active Publication Date: 2019-01-15
HUBEI LIYI PHARM TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After reviewing a large number of Chinese and foreign patent and non-patent literature, there is no literature report using chiral column high performance liquid chromatography to detect the purity of the four isomers of the intermediate condensate, which is not conducive to the company's control of product quality

Method used

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  • High performance liquid chromatography (HPLC) detection method for valganciclovir hydrochloride intermediate condensation product isomer
  • High performance liquid chromatography (HPLC) detection method for valganciclovir hydrochloride intermediate condensation product isomer
  • High performance liquid chromatography (HPLC) detection method for valganciclovir hydrochloride intermediate condensation product isomer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Separation and analysis of different chiral columns Four chiral configurations of valganciclovir hydrochloride intermediate condensate, the steps are as follows:

[0052] (1) Stationary phase: cellulose-tris(3,5-dichlorophenylcarbamate) bonded silica gel;

[0053] Column: IC 4.6*250mm, 5um;

[0054] Chromatographic instrument: Agilent 1200 high performance liquid chromatograph;

[0055] Detector and wavelength: UV-254nm;

[0056] Mobile phase: n-hexane-absolute ethanol, (50:50, v / v);

[0057] Flow rate: 1.5ml / min;

[0058] Injection volume: 5ul;

[0059] Column temperature: 35°C;

[0060] Preparation of the test solution:

[0061] D-condensate reference substance solution: Accurately weigh about 25 mg of D-condensate reference substance, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, and shake well.

[0062] L-condensate reference substance solution: Accurately weigh about 25 mg of L-condensate reference substanc...

Embodiment 2

[0110] Example 2 Different mobile phases and ratio separation and analysis of four chiral configurations of valganciclovir hydrochloride intermediate condensate, the steps are as follows:

[0111] Chromatographic conditions:

[0112] (1) Mobile phase: water-acetonitrile (70:30, v / v);

[0113] (2) Mobile phase: water-acetonitrile (63:37, v / v);

[0114] (3) Mobile phase: water-acetonitrile (60:40, v / v);

[0115] Stationary phase: cellulose-tris(4-chloro-3-methylphenylcarbamate) coated silica gel;

[0116] Chromatographic instrument: Agilent 1260 high performance liquid chromatograph;

[0117] Column: OX-3R 4.6*150mm, 3um;

[0118] Detector and wavelength: UV-254nm;

[0119] Flow rate: 0.5ml / min;

[0120] Injection volume: 10ul;

[0121] Column temperature: 15°C;

[0122] Preparation of the test solution:

[0123] Diluent: water-acetonitrile (50:50, v / v).

[0124] Using experiment (four) in Example 1 to use cellulose-three (4-chloro-3-methylphenylcarbamate) coated sil...

Embodiment 3

[0130] Example 3 Separate and analyze four chiral configurations of valganciclovir hydrochloride intermediate condensate at different column temperatures, the steps are as follows:

[0131] (1) Column temperature: 20°C;

[0132] (2) Column temperature: 10°C;

[0133] Stationary phase: cellulose-tris(4-chloro-3-methylphenylcarbamate) coated silica gel;

[0134] Chromatographic instrument: Agilent 1260 high performance liquid chromatograph;

[0135] Column: OX-3R 4.6*150mm, 3um;

[0136] Detector and wavelength: UV-254nm;

[0137] Mobile phase: water-acetonitrile (63:37, v / v);

[0138] Flow rate: 0.5ml / min;

[0139] Injection volume: 10ul;

[0140] Preparation of the test solution:

[0141] Diluent: water-acetonitrile (50:50, v / v).

[0142] Using experiment (four) in Example 1 to use cellulose-three (4-chloro-3-methylphenylcarbamate) to coat silica gel as the stationary phase, the L-condensate and D-condensate mixed control prepared The sample solution was used as the...

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Abstract

The invention belongs to the field of pharmaceutical analysis, and particularly discloses a high performance liquid chromatography (HPLC) detection method for a valganciclovir hydrochloride intermediate condensation product isomer. According to the method, cellulose-tri(4,-chlorine-3-methyl phenyl carbamate) coating silica gel is used as a chiral column of a filling agent, a mixed solution of water and nitrile is used as a mobile phase, the column temperature is 10-20 DEG C, the flowing speed is 0.4-0.6ml / min, and the wavelength is 250-260 nanometers. By the method, effective separation of four isomers of a valganciclovir hydrochloride intermediate condensation product is achieved, the method has the advantages of good detection result accuracy, high sensitivity, low cost and short analysis time and is simple and convenient to operate, and a guarantee is provided for quality control of the valganciclovir hydrochloride intermediate condensation product.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to an HPLC detection method for condensate isomers of valganciclovir hydrochloride intermediates. Background technique [0002] Valganciclovir hydrochloride is a synthetic inhibitor of herpes virus DNA, developed by the Swiss company Roche, and first listed as a prescription drug in Sweden and Finland in 2010, for the treatment of giant cells in patients with acquired immunodeficiency syndrome (AIDS) Viral (CMV) retinitis and prevention of CMV infection in high-risk solid organ transplant patients. In March 2001, it was approved by the US FDA, and in May 2001 it was first launched in the US. A number of studies at home and abroad have shown that valganciclovir hydrochloride tablets have obvious pharmacological effects, novel mechanism of action, low toxicity, few adverse reactions, significant clinical efficacy, high patient compliance, and safe application. [0003] The intermediate ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 刘俊余再丹柳旭邓亚萍邵振周震刘欣
Owner HUBEI LIYI PHARM TECH CO LTD
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