A kind of detection method of genotoxic impurity in tenofovir alafenamide fumarate

A technology of propofol fumarate and tenofovir, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of failing to meet the detection requirements of genotoxic impurities, low detection sensitivity, and unstable test products, etc. Achieve the effect of good applicability, low detection limit and good applicability

Active Publication Date: 2021-09-03
HINYE PHARM CO LTD
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  • Application Information

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Problems solved by technology

At present, gas chromatography is used to detect the genotoxic impurity triphenyl phosphite in tenofovir alafenamide fumarate API, but the detection cost of this method is high, and the test product itself is unstable in the derivatization process, causing great interference. The detection sensitivity is low and cannot meet the detection requirements of genotoxic impurities

Method used

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  • A kind of detection method of genotoxic impurity in tenofovir alafenamide fumarate
  • A kind of detection method of genotoxic impurity in tenofovir alafenamide fumarate
  • A kind of detection method of genotoxic impurity in tenofovir alafenamide fumarate

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Embodiment 1

[0069] A detection method for genotoxic impurities in tenofovir alafenamide fumarate, comprising the following steps:

[0070] S1, solution preparation:

[0071] Blank solution: Mix acetonitrile and water at a volume ratio of 80:20, set aside.

[0072] Reference substance stock solution: Accurately weigh about 12 mg of the reference substance, accurately weigh it, put it in a 20mL measuring bottle, dissolve it with a diluent and dilute to the mark, shake well, and get it.

[0073] 20 times limit reference substance solution:

[0074] (1) Accurately measure 1.0mL of the above-mentioned stock solution of the reference substance, put it in a 50mL measuring bottle, add diluent to dilute to the mark, shake well, and obtain the diluent;

[0075] (2), and then accurately measure 0.5mL of the diluent, put it in a 20mL measuring bottle, add the diluent to the mark, shake well, and it is ready.

[0076] Reference substance solution: Accurately measure 1mL of the above-mentioned 20-fo...

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Abstract

The invention discloses a detection method for genotoxic impurities in tenofovir alafenamide fumarate, which comprises the following steps: S1, taking the test product to prepare the test product solution; S2, high performance liquid chromatography detection; The chromatographic detection includes the following conditions: mobile phase A: phosphoric acid solution; mobile phase B: acetonitrile; elution method: gradient elution. It detects the genotoxic impurity triphenyl phosphite in the finished product tenofovir alafenamide fumarate bulk drug by high performance liquid chromatography; realizes the quality control of the genotoxic impurity triphenyl phosphite. The detection method of the invention has good applicability, good specificity, low detection limit, high sensitivity, good linear relationship, high accuracy, good repeatability, high precision, good stability and good durability.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting genotoxic impurities in tenofovir alafenamide fumarate. Background technique [0002] Tenofovir disoproxil fumarate is a new type of nucleotide reverse transcriptase inhibitor tenofovir prodrug, clinically used for the treatment of AIDS and chronic hepatitis B. During the synthesis and storage of tenofovir disoproxil fumarate, various impurities will be introduced, and the genotoxic impurity triphenyl phosphite is one of them. [0003] Genotoxic impurities refer to substances in drugs that can directly or indirectly damage cell DNA and produce mutagenic or carcinogenic effects. Genotoxic impurities, as a type of process impurities, have received great attention at home and abroad in recent years. At present, gas chromatography is used to detect the genotoxic impurity triphenyl phosphite in tenofovir alafenamide fumarate API, but the detection cost o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 刘栋华尚金凤陈鸿玉李承龙
Owner HINYE PHARM CO LTD
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