Method for detecting content of impurities in etravirine intermediate 1

Abstract

The invention relates to the technical field of pharmaceutical analysis, and discloses a method for detecting the content of impurities in an etravirine intermediate 1, the method comprises the following steps: step 1, treating the etravirine intermediate 1 by using a chromatographic column in which octadecylsilane bonded silane is used as a filling agent; step 2, carrying out gradient elution by taking an organic phase and a water phase as mobile phases; and step 3, carrying out high performance liquid chromatography analysis and determination, and determining the content of the etravirine intermediate 1 and the six impurities of the etravirine intermediate 1. The method for detecting the content of the impurities in the etravirine intermediate 1 is simple in process and low in cost, a gradient elution method is adopted, the content of the impurities in the etravirine intermediate 1 can be measured, and the detection method is scientific, reasonable and objective, so that the quality of etravirine can be better controlled.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting the content of impurities in etravirine intermediate 1. Background technique [0002] Etravirine intermediate 1,4-((2,6-dichloropyrimidine-4-benzyl)oxy)-3,5-dimethylbenzonitrile, its molecular formula is C13H9N3Cl2O, its molecular weight is 294, [0003] The structural formula is: , [0004] Etravirine can be used in combination with other antiretroviral drugs in adult HIV-1 infected patients who have developed drug resistance after initial treatment with antiretroviral drugs. [0005] Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1), which can directly bind to HIV-1 reverse transcriptase and block RNA by destroying the catalytic site of the enzyme Etravirine does not inhibit human α-, β- and γ-type DNA polymerase activity. [0006] The method for impurity content detection in e...

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Problems solved by technology

[0007] Aiming at the deficiencies in the prior art, the present invention provides a method for detecting the content of impurities in etravirine intermediate 1, which can measure the content of impurities in etravirine intermediate 1, and the detection method is scientific, reasonable and objective, so that it can be more The advantages of controlling the quality of etravirine well solve the method for detecting the impurity content in etravirine intermediate 1 in the current prior art, and it is difficult to measure the content of etravirine intermediate 1 impurity, which cannot be scientifically , reasonable and objective testing, it is difficult to better control the quality of etravirine 1

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