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A kind of analytical detection method of valganciclovir hydrochloride impurity

A valganciclovir hydrochloride and detection method technology, which is applied in the field of analysis and detection of valganciclovir hydrochloride impurities, can solve problems such as separation difficulties, and achieve the effects of high sensitivity, good linear relationship, and good accuracy

Active Publication Date: 2017-03-08
HUBEI LIYI PHARM TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the above technical problems, the present invention creatively adds a certain concentration of ammonium-containing formate or acetate into the mobile phase for the first time, which completely solves the difficult problem of separation between the main peak and impurity peaks and adjacent impurity peaks, and is easy to operate , high sensitivity, good accuracy

Method used

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  • A kind of analytical detection method of valganciclovir hydrochloride impurity
  • A kind of analytical detection method of valganciclovir hydrochloride impurity
  • A kind of analytical detection method of valganciclovir hydrochloride impurity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Chromatographic conditions: use phenylsilane-bonded silica gel as the filler, and the mobile phase is triethylamine ammonium formate buffer with pH=5.6 (in addition to water, it contains three components, triethylamine, ammonium formate and trifluoroacetic acid, and its content Respectively: 0.2% (v / v) triethylamine, 0.05mol / L ammonium formate and an appropriate amount of trifluoroacetic acid, wherein an appropriate amount of trifluoroacetic acid is used to adjust the pH of the buffer to 5.6)-methanol, the The volume ratio of buffer to methanol was 95:5, the flow rate was 1.0 ml / min, the detection wavelength was 254 nm, the chromatographic column: COSMOSIL 5PE-MS 150×4.6 mm, 5 μm, the column temperature was 35 °C, and the injection volume: 50 μl.

[0043] Preparation of the test solution:

[0044] Take about 50 mg of valganciclovir hydrochloride crude drug, accurately weigh it, put it in a 100 ml volumetric flask, add 0.001 mol / L hydrochloric acid to dissolve and dilute...

Embodiment 2

[0052] Chromatographic conditions: use phenylsilane-bonded silica gel as filler, and the mobile phase is triethylamine ammonium acetate buffer with pH=5.3 (in addition to water, it contains three components, triethylamine, ammonium acetate and formic acid, whose contents are : 0.25% (v / v) triethylamine, 0.03 mol / L ammonium acetate and an appropriate amount of formic acid, wherein an appropriate amount of formic acid is used to adjust the pH value of the buffer to 5.3)-methanol, the volume of the buffer and methanol The ratio was 95:5, the flow rate was 1.0 ml / min, the detection wavelength was 254 nm, the chromatographic column: COSMOSIL5PE-MS 150×4.6 mm, 5 μm, the column temperature was 35° C., and the injection volume was 50 μl.

[0053] Preparation of the test solution:

[0054] Take about 50mg of valganciclovir hydrochloride raw material, accurately weigh it, put it in a 100ml volumetric flask, add an appropriate amount of each of the six impurities, and prepare it into gua...

Embodiment 3

[0059] Chromatographic conditions: use phenylsilane-bonded silica gel as filler, and the mobile phase is triethylamine ammonium acetate buffer with pH=5.4 (in addition to water, it contains three components, triethylamine, ammonium acetate and trifluoroacetic acid. Respectively: 0.35% (v / v) triethylamine, 0.03 mol / L ammonium acetate and an appropriate amount of trifluoroacetic acid, wherein an appropriate amount of trifluoroacetic acid is used to adjust the pH of the buffer to 5.4)-methanol, the The volume ratio of buffer to methanol was 96:4, the flow rate was 1.0 ml / min, the detection wavelength was 254 nm, the chromatographic column: COSMOSIL 5PE-MS 150×4.6 mm, 5 μm, the column temperature was 30 °C, and the injection volume was 50 μl.

[0060] Preparation of the test solution:

[0061] Take valganciclovir hydrochloride tablets, grind them finely, accurately weigh an appropriate amount (approximately equivalent to 50 mg of the main drug containing valganciclovir hydrochlori...

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Abstract

The invention belongs to the technical field of analytical chemistry, and specifically discloses an HPLC analysis and detection method for valganciclovir hydrochloride impurities, more specifically, relates to an analysis and detection method for guanine, ganciclovir, and methoxymethylguanine Purine, ganciclovir 1‑N‑methylvaline ester, monoacetoxy ganciclovir, monochloroganciclovir, or drugs containing the impurities in the above 6 or their preparations. The solution to be tested is injected into a high-performance liquid chromatography column with phenylsilane-bonded silica gel as a filler, washed and separated with a mobile phase composed of an amine-containing inorganic salt solution and a chromatographically pure organic solvent, and then analyzed and detected by ultraviolet light. For the first time, this method creatively adds a certain concentration of ammonium acetate or ammonium formate into the mobile phase, which completely solves the difficult problem of separation between the main peak and impurity peaks and adjacent impurity peaks. It is easy to operate, high in resolution, high in sensitivity and good in accuracy. , after literature search, there is no similar literature report.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a HPLC analysis and detection method for valganciclovir hydrochloride impurities, and more particularly, to a method for analyzing and detecting guanine, ganciclovir and methoxymethylguanine , Ganciclovir 1-N-methyl valine ester, monoacetoxy ganciclovir, monochloroganciclovir or the medicine containing the impurities in the above 6 or the method for the preparation thereof. Background technique [0002] During the synthesis process of valganciclovir hydrochloride bulk drug and during the placement of valganciclovir hydrochloride solid preparations, six main impurities may be produced, namely guanine, ganciclovir, methoxymethylguanine , Ganciclovir 1-N-methyl valine ester, monoacetoxy ganciclovir, monochloroganciclovir. [0003] The content of the above-mentioned 6 impurities directly affects the quality of valganciclovir hydrochloride or its preparation, easily caus...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/34
Inventor 史自东刘俊陈龙洪华云周震李霞余玉静
Owner HUBEI LIYI PHARM TECH CO LTD
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