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Method for determining bromoethane in tenofovir alafenamide

A technique for tenofovir alafenamide and a determination method, which is applied in the field of pharmaceutical analysis, can solve the problems of complex method, low sensitivity and accuracy, and achieves the effects of simple operation, high sensitivity and high accuracy

Inactive Publication Date: 2020-03-20
HENAN TIANSHENG TAIFENG PHARM TECH CO LTD
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  • Abstract
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  • Claims
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Problems solved by technology

There are many domestic literature reports on the determination method of bromoethane, but the determination of bromoethane in tenofovir alafenamide is rarely reported in China at present, there are occasional reports and the method is complicated, and the sensitivity and accuracy are not high

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  • Method for determining bromoethane in tenofovir alafenamide
  • Method for determining bromoethane in tenofovir alafenamide
  • Method for determining bromoethane in tenofovir alafenamide

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Embodiment Construction

[0009] The following examples only illustrate the specific steps of the present invention, but are not limited by the examples. The present invention will be further described in detail below in conjunction with specific examples and with reference to data. It should be understood that these examples are only for illustrating the present invention, rather than limiting the scope of the present invention in any way.

[0010] (1) Selection of solvent

[0011] Tenofovir alafenamide is dissolved in organic solvents such as methanol, acetonitrile, acetone and dimethylformamide. Due to the low limit of ethyl bromide, it is necessary to dissolve tenofovir alafenamide as much as possible. According to the solubility information of tenofovir alafenamide, methanol, acetonitrile, acetone and dimethylformamide can be used as solvents. The boiling point of dimethylformamide is 152.8°C, and the difference between the boiling points of dimethylformamide and ethyl bromide is large, so dimeth...

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Abstract

The invention provides a method for determining bromoethane in tenofovir alafenamide by adopting a direct solution sampling method. The method comprises the following steps: preparing tenofovir alafenamide into a certain solution, measuring trace bromoethane by using a capillary column taking 6% cyanopropylphenyl-94% dimethyl polysiloxane as a stationary liquid, and calculating the content of bromoethane in tenofovir alafenamide by using an external standard method. According to the method disclosed by the invention, the tenofovir alafenamide is prepared into the solution only by using a proper solvent, the pretreatment is simple, the operation is easy, and the content of bromoethane in the tenofovir alafenamide can be better determined.

Description

technical field [0001] The invention belongs to the field of pharmaceutical analysis and specifically designs a method for determining ethyl bromide in tenofovir alafenamide. Background technique [0002] In the synthetic route of tenofovir alafenamide, bromoethane may be produced as a by-product during the reaction. On October 27, 2017, the International Agency for Research on Cancer of the World Health Organization released the "Reference for the Preliminary List of Carcinogens", and ethyl bromide belongs to category 3 carcinogens. There are many domestic reports on the determination of ethyl bromide, but there are few domestic reports on the determination of ethyl bromide in tenofovir alafenamide. There are occasional reports and the method is complicated, and the sensitivity and accuracy are not high. [0003] Ethyl bromide is a colorless oily liquid with an ether-like odor and burning smell. Exposure to air or exposure to light gradually turns yellow, easy to volatili...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 沙薇吴金平李晨希
Owner HENAN TIANSHENG TAIFENG PHARM TECH CO LTD
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