Method for separating and detecting tenofovir alafenamide and relevant substances thereof

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: 2017-09-19
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0014] 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
[0015] I

Method used

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  • Method for separating and detecting tenofovir alafenamide and relevant substances thereof
  • Method for separating and detecting tenofovir alafenamide and relevant substances thereof
  • Method for separating and detecting tenofovir alafenamide and relevant substances thereof

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Embodiment Construction

[0028] The invention provides a method for separating and detecting tenofovir alafenamide and its related substances. The method uses an octadecyl-bonded ethylene bridge hybrid silica gel chromatographic column, and the phase A can have a pH value of 1.0 to 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 ultraviolet The detector detects.

[0029] 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 the XBridge BEH C18 may 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...

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Abstract

The invention relates to a method for separating and detecting tenofovir alafenamide and relevant substances thereof. The method can be used for detecting a tenofovir alafenamide sample by adopting an octadecyl-bonded ethylene bridge hybridization silica gel chromatographic column. According to the separating and detecting method disclosed by the invention, diastereomers and other relevant substances of the tenofovir alafenamide can be effectively separated and detected. The method has the characteristics of simplicity, convenience, accuracy and reliability, and is suitable for controlling the quality of tenofovir alafenamide products in industry.

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, whose English name is Tenofovir Alafenamide, is a prodrug of tenofovir (code name GS-7340) launched by Gilead for anti-HIV and hepatitis B virus. [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, as in 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 t...

Claims

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Application Information

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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
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