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A kind of method for separating and detecting tenofovir alafenamide and related substances

A technology for tenofovir alafenamide and related substances, which is applied in the field of separation and detection of tenofovir alafenamide and related substances, and can solve the problems of not providing

Active Publication Date: 2021-08-10
SUNSHINE LAKE PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0013] The method can effectively separate and detect tenofovir alafenamide and one of its diastereoisomers, but it cannot effectively separate and detect other diastereomers at the same time, as well as other existing relative substance
[0014] In the current analysis and detection method of tenofovir alafenamide, there is no simple, accurate and reliable method for simultaneous detection of tenofovir alafenamide and its 3 pairs of diastereoisomers and other methods related to substances

Method used

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  • A kind of method for separating and detecting tenofovir alafenamide and related substances
  • A kind of method for separating and detecting tenofovir alafenamide and related substances
  • A kind of method for separating and detecting tenofovir alafenamide and related substances

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Embodiment Construction

[0029] The invention provides a method for separating and detecting tenofovir alafenamide and its related substances. The method adopts an octadecyl-bonded ethylene bridge hybrid silica gel chromatographic column, and the phase A can have a pH value of 1.0~ 7.0 buffered saline solution or a mixture of buffered saline solution and a certain proportion of organic solution (such as methanol, ethanol or isopropanol, etc.), phase B is methanol, ethanol or isopropanol, gradient elution samples, using UV The detector detects.

[0030] In the analysis method provided by the present invention, the octadecyl-bonded ethylene bridged hybrid silica gel chromatographic column can be XBridge BEH C18. Specifically, the specific specifications of XBridge BEH C18 can be 1 mm to 4.6 mm in diameter, 30 mm to 250 mm in column length, and 1.7 to 10 μm in particle size, such as XBridge BEH C18, 4.6 × 75 mm, 2.5 μm. According to the common knowledge in the field, those skilled in the art can select ...

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Abstract

The invention relates to a method for separating and detecting tenofovir alafenamide and its related substances. Amine samples were tested. The separation and detection method of the present invention can effectively separate and detect diastereomers and other related substances of tenofovir alafenamide. The method is simple, accurate and reliable, and is suitable for controlling tenofovir alafenamide in industry. Product quality of lafenamide.

Description

technical field [0001] The invention relates to the field of medical analysis and detection, and more specifically relates to a method for separating and detecting tenofovir alafenamide and its related substances. Background technique [0002] Tenofovir alafenamide has the following structural formula: [0003] . [0004] Tenofovir alafenamide, the English name is Tenofovir Alafenamide, is a prodrug of tenofovir against HIV and hepatitis B virus (code name GS-7340) launched by Gilead. [0005] Tenofovir alafenamide is a compound containing 3 chiral centers, and it should theoretically have 7 optical isomers (including 3 pairs of diastereoisomers and 1 enantiomer), all of which are For impurities. In the existing synthesis process, such as the route disclosed in WO2002008241A2, the enantiomers of tenofovir alafenamide are obtained by introducing chiral starting materials PMPA (tenofovir) and L -Alanine is controlled separately, so the content of enantiomers existing in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/60G01N30/74
CPCG01N30/02G01N30/6052G01N30/74G01N2030/027
Inventor 文景兵范晓梅饶万兵黄文清刘国柱栾保磊李哲
Owner SUNSHINE LAKE PHARM CO LTD