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A kind of hplc assay method of related substances in Favipiravir

A technology of favipiravir and related substances, which is applied in the field of drug analysis and detection, can solve problems that have not yet been retrieved, and achieve the effects of improving credibility, improving detection sensitivity, and good product quality

Active Publication Date: 2016-09-21
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, no HPLC method for determination of favipiravir related substances has been retrieved

Method used

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  • A kind of hplc assay method of related substances in Favipiravir
  • A kind of hplc assay method of related substances in Favipiravir
  • A kind of hplc assay method of related substances in Favipiravir

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1 Chromatographic conditions and system suitability test

[0023] 1.1 Selection of chromatographic conditions

[0024] Instrument: Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5, the optimum column temperature is 30°C, and the flow rate is 1.0ml / min. The liquid chromatography column uses octadecylsilane bonded silica gel as the filler (250mm×4.6mm, 5μm). Referring to the relevant literature and combined with the specific conditions of the test, methanol-water, acetonitrile-water, methanol-acetonitrile-water, methanol-acetonitrile-water, and Various conditions such as methanol-acetonitrile-phosphate solution, and finally determine that the mobile phase is composed of acetonitrile (mobile phase A)-phosphate solution (mobile phase B), wherein the concentration range of phosphate solution (mobile phase B) is 0.005~0.015mmol / L, adjust the pH range from 6.0 to 8.0, the optimal concentration is 0.01mol / L, the optimal pH value is about 7.0, and carry out gradient elution acco...

Embodiment 2

[0039] Determination of related substances of embodiment 2 Favipiravir tablets

[0040] Take 20 tablets of this product, accurately weigh, grind finely, accurately weigh an appropriate amount (approximately equivalent to 2 mg of Favipiravir), add mobile phase to prepare a solution containing 0.2 mg per 1 ml, filter, and take the filtrate as the test sample Solution: Accurately measure an appropriate amount of the test solution, add mobile phase and dilute it to contain about 2 μg of solution per 1 ml, as a control solution. Under the following selected chromatographic conditions: a diode array detector (Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5), using octadecylsilane bonded silica gel as a filler, and a mobile phase consisting of Acetonitrile (mobile phase A)-phosphate solution (mobile phase B), wherein the concentration range of phosphate solution (mobile phase B) is 0.005-0.015mol / L, adjust the pH range to 6.0-8.0, and its optimal concentration is 0.01mol / L, the opti...

Embodiment 3

[0044] Determination of related substances of embodiment 3 Favipiravir capsules

[0045] Get an appropriate amount of the content of this product, grind it finely, precisely weigh the fine powder (approximately equivalent to 2 mg of Favipiravir), add mobile phase to prepare a solution containing 0.2 mg per 1 ml, filter, and take the filtrate as the test solution. Precisely measure an appropriate amount of the test solution, add mobile phase and dilute it to contain about 2 μg of solution per 1 ml, as a control solution. Under the following selected chromatographic conditions: a diode array detector (Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5), using octadecylsilane bonded silica gel as a filler, and a mobile phase consisting of Acetonitrile (mobile phase A)-phosphate solution (mobile phase B), wherein the concentration range of phosphate solution (mobile phase B) is 0.005-0.015mol / L, adjust the pH range to 6.0-8.0, and its optimal concentration is 0.01mol / L, the optimum ...

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Abstract

The invention discloses an HPLC method for measuring related substances in Favipiravir. According to the HPLC method for measuring related substances in Favipiravir, disclosed by the invention, specifically, a diode array detector is adopted, and acetonitrile (mobile phase A)-phosphate solution (mobile phase B) serves as a mobile phase. The method comprises the following steps: taking a proper amount of Favipiravir and related preparations containing Favipiravir, adding the substances into the mobile phase for preparing a solution of which every 1ml contains 0.2mg of Favipiravir, and taking the solution as a test solution; diluting into a solution of which every 1ml contains about 0.2mu g of Favipiravir by using the mobile phase, and taking the solution as a contrast solution; respectively performing sample introduction, wherein the sum of each impurity peak area in the chromatogram of the test solution is not more than the main peak area of the contrast solution. According to the method for detecting the related substances in Favipiravir and related preparations containing Favipiravir, disclosed by the invention, the conditions of the impurities and degradation products of Favipiravir can be rapidly and accurately detected. The operation is simple and convenient, the sensitivity is high, and the product quality can be well controlled.

Description

technical field [0001] The invention relates to a method for detecting related substances of favipiravir and related preparations containing favipiravir, belonging to the field of drug analysis and detection. Background technique [0002] Favipiravir is an influenza treatment drug that has a different mechanism of action from many anti-influenza drugs. Drugs such as Tamiflu prevent the infection from exacerbating by preventing the proliferating virus from drilling out of the cell; Favipiravir inhibits the proliferation of the virus itself by hindering gene replication in the cell. Since influenza virus and Ebola virus are both RNA viruses, Favipiravir may hinder the proliferation of Ebola virus in cells, thereby curbing infection. Because favipiravir may introduce residual raw materials and other related substances in the synthesis process, and may also produce degradation products in the storage process, the present invention carries out purity analysis to favipiravir, ado...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/74
Inventor 冯光玲丁文娟邓玉晓赵仁永龚艳艳段崇刚孙晋瑞
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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