A method for determining related substances in Sofosbuvir tablets by HPLC

A technology of sofosbuvir tablets and related substances, which is applied in the field of medicine and chemical industry, can solve the problems of no public detection of sofosbuvir tablets, etc., and achieve the effects of improving chromatographic retention behavior, improving symmetry, and high sensitivity

Active Publication Date: 2016-04-20
SUNSHINE LAKE PHARM CO LTD
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Problems solved by technology

[0006] There is no analytical method for detecting related substances in Sofosbuvir tablets disclosed in the prior art, and drug quality control is very important in the process of medicine preparation and use, so it is necessary to develop an effective separation and determination of Sofosbuvir Analytical methods for related substances in tablets are very necessary

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  • A method for determining related substances in Sofosbuvir tablets by HPLC
  • A method for determining related substances in Sofosbuvir tablets by HPLC
  • A method for determining related substances in Sofosbuvir tablets by HPLC

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Embodiment Construction

[0016] A kind of method that uses HPLC to separate and measure related substances of Sofosbuvir tablets provided by the invention is characterized in that in the HPLC system, the reversed-phase C18 column through end-capping treatment is used as the analytical column, and the mobile phase is composed of a buffer and an organic phase , carry out gradient elution, and use an ultraviolet detector to detect; wherein the buffer solution is phosphoric acid aqueous solution or phosphoric acid aqueous solution-organic solvent mixed solution, wherein the organic phase is an organic solvent.

[0017] The reversed-phase C18 column may be WatersXSelectHSST3; in some embodiments, the reversed-phase C18 column is WatersXSelectHSST3 (4.6×100 mm, 2.5 μm).

[0018] The phosphoric acid concentration in the phosphoric acid aqueous solution is not more than 0.5% (w / v); preferably, the phosphoric acid concentration in the phosphoric acid aqueous solution is about 0.05-0.2%, (w / v).

[0019] The org...

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Abstract

The invention provides a method for measuring related substances of a Sofosbuvir tablet by using HPLC. The method is characterized in that in an anti-phase C18 column, a phosphoric acid solution or a mixed solution of the phosphoric acid solution and an organic phase is adopted to carry out gradient elution detection on a Sofosbuvir tablet test solution, wherein termination processing is carried out on silica gel particles of the anti-phase C18 column. The method provided by the invention can effectively separate and measure the related substances of the Sofosbuvir tablet, and also has the characteristics of being good in specificity, high in sensitivity, convenient, rapid, economical, and low in cost.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and more specifically relates to a method for determining related substances of sofosbuvir tablets by HPLC. Background technique [0002] Sofosbuvir, chemical name (S)-isopropyl-2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- Dihydropyridin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2yl)methoxy)-(phenoxy)phosphoramido)propionate, its chemical structure as follows: [0003] [0004] It is a new drug developed by Gilead for the treatment of chronic hepatitis C. It was approved by the US Food and Drug Administration (FDA) for marketing in the United States on December 6, 2013. The trade name is Sovaldi. [0005] Chinese patent application CN101918425A discloses a sofosbuvir compound and a preparation method thereof, so sofosbuvir is a compound known to the public. [0006] There is no analytical method for detecting related substances in Sofosbuvir tablets disclosed in the prio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
Inventor 姜曼花黄林正高美玲宋学志黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD
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