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Method for detecting HPLC of valganciclovir hydrochloride intermediate hydrolysate isomers

A valganciclovir hydrochloride and detection method technology, which is applied in the field of drug analysis, can solve the problems of unfavorable enterprise product quality control, detection of the purity of the four isomers of intermediate hydrolyzates, etc., to achieve simple research and development and production, Reliable analysis and detection methods, the effect of improving quality

Active Publication Date: 2018-07-10
HUBEI LIYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After consulting a large number of Chinese and foreign literature and patents, there is no literature report on the detection of the purity of the four isomers of the intermediate hydrolyzate by high performance liquid chromatography, which is not conducive to the control of product quality by enterprises

Method used

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  • Method for detecting HPLC of valganciclovir hydrochloride intermediate hydrolysate isomers
  • Method for detecting HPLC of valganciclovir hydrochloride intermediate hydrolysate isomers
  • Method for detecting HPLC of valganciclovir hydrochloride intermediate hydrolysate isomers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The separation effect test of different chiral columns of embodiment 1

[0047] (1) Stationary phase: silica gel surface coated with chiral crown ether

[0048] Column: CR(+)4.6*150mm, 5um

[0049] Chromatographic instrument: Agilent 1200 high performance liquid chromatograph

[0050] Detector and wavelength: UV-254

[0051] Mobile phase: Perchloric acid aqueous solution at pH 1.0

[0052] Flow rate: 0.8ml / min

[0053] Injection volume: 5ul

[0054] Column temperature: 25°C

[0055] Preparation of the test solution:

[0056] L-hydrolyzate and D-hydrolyzate mixed reference substance solution: Accurately weigh about 5 mg of D-hydrolyzate reference substance and about 5 mg of L-hydrolyzate reference substance, put them in the same 10ml measuring bottle, add mobile phase to dissolve and dilute to scale, shake well.

[0057] Take 5 μl of the above solution and inject it into the liquid chromatograph, record the chromatogram, the result is as follows: figure 1 show...

Embodiment 2

[0100] The detection effect test of embodiment 2 different mobile phases and their proportions

[0101] Chromatographic conditions:

[0102] (1) Mobile phase: n-heptane-ethanol (70:30, v / v)

[0103] (2) Mobile phase: n-hexane-isopropanol (50:50, v / v)

[0104] (3) Mobile phase: n-hexane-n-butanol (50:50, v / v)

[0105] (4) Mobile phase: n-hexane-ethanol (75:25, v / v)

[0106] (5) Mobile phase: n-hexane-ethanol (65:35, v / v)

[0107] Chromatographic instrument: Agilent 1200 high performance liquid chromatograph

[0108] Column: IC 4.6*250mm, 5um

[0109] Detector and wavelength: UV-254

[0110] Flow rate: 1.5ml / min

[0111] Injection volume: 5ul

[0112] Column temperature: 35°C

[0113] Preparation of the test solution:

[0114] Diluent: n-hexane-ethanol (50:50, v / v).

[0115] L-hydrolyzate and D-hydrolyzate mixed reference substance solution: Accurately weigh about 5 mg of D-hydrolyzate reference substance and about 5 mg of L-hydrolyzate reference substance, put them...

Embodiment 3

[0123] The detection effect test of embodiment 3 different wavelengths

[0124] (1) Detection wavelength: UV-250

[0125] (2) Detection wavelength: UV-260

[0126] (3) Detection wavelength: UV-254

[0127] Chromatographic instrument: Agilent 1200 high performance liquid chromatograph

[0128] Column: IC 4.6*250mm, 5um

[0129] Mobile phase: n-hexane-ethanol (70:30, v / v)

[0130] Flow rate: 1.5ml / min

[0131] Injection volume: 5ul

[0132] Column temperature: 35°C

[0133] Preparation of the test solution:

[0134] Diluent: n-hexane-ethanol (50:50, v / v).

[0135] L-hydrolyzate and D-hydrolyzate mixed reference substance solution: Accurately weigh about 5 mg of D-hydrolyzate reference substance and about 5 mg of L-hydrolyzate reference substance, put them in the same 10ml measuring bottle, add diluent to dissolve and dilute to scale, shake well.

[0136](1) The retention time of the L-hydrolyzate in (1) is 13.197min, 15.090min, the minimum resolution between the four...

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Abstract

The invention belongs to the field of pharmaceutical analysis, and particularly discloses a method for detecting HPLC of valganciclovir hydrochloride intermediate hydrolysate isomers. The method useschiral HPLC columns taking cellulose-3(3,5-dichloro phenyl amino formic ether) bonded silica gel as a stuffing bulking agent, and takes a mixed solution of hydrocarbon alkyl and alcohols as mobile phase, the column temperature is 20-40 DEG C, the flow velocity is 1.0-1.5 milliliters per minute, and the wave length is 250-260 nanometers. The method for detecting the HPLC of valganciclovir hydrochloride intermediate hydrolysate isomer has the advantages that the effective segregation of four isomers of the valganciclovir hydrochloride intermediate hydrolysate is achieved, the accuracy of the detection result is good, the sensitivity is high, the operation is simple and convenient, the cost is low, the analysis time is short, and guarantee is provided for the quality control of the valganciclovir hydrochloride intermediate hydrolysate.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to an HPLC detection method for hydrolyzate 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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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 柳旭余再丹刘俊邓亚萍邵振周震刘欣
Owner HUBEI LIYI PHARM TECH CO LTD
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