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Method for detecting avanafil and related impurities thereof

A detection method and avanafil technology, which can be used in measurement devices, instruments, scientific instruments, etc., can solve problems such as identification of unimpurity structures

Pending Publication Date: 2022-04-05
HARVEST PHARMA HUNAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The existing technology uses liquid chromatography to separate the known impurities in avanafil, and does not identify the structure of the impurities, which has certain limitations

Method used

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  • Method for detecting avanafil and related impurities thereof
  • Method for detecting avanafil and related impurities thereof
  • Method for detecting avanafil and related impurities thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Avanafil test solution 1 is detected by UPLC method, and the results are as follows: figure 1 Shown, the content of impurity A, B, C, D is respectively 0.89%, 0.57%, 0.57% and 1.44%.

[0024] Avanafil test solution 1 was separated and identified by LC-MS method. The results showed that there was a [M+H]+ peak of 393.2 in impurity A, a [M+H]+ peak of 430.8 in impurity B, and a [M+H]+ peak of 450 in impurity C. The [M+H]+ peak and the impurity D have a [M+H]+ peak of 858.0.

[0025] Table 1 and Table 2 are the detection data of avanafil test solution 1.

[0026] Table 1 Retention time and resolution of avanafil and its related impurities

[0027] name retention time (min) Separation Impurity A 4.29 - Impurity C 5.02 5.35±0.03 Avanafil 5.44 2.81±0.03 Impurity B 6.02 3.88±0.03 Impurity D 7.85 12.35±0.1

[0028] Table 2 Linearity and Sensitivity

[0029]

[0030] After detection and verification, impurity A is 4-{[(...

Embodiment 2

[0032] Avanafil test solution 2 is detected by UPLC method, and the results are shown in Table 3:

[0033] Table 3 Content and resolution of avanafil and related impurities

[0034]

[0035]

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Abstract

The invention discloses a method for detecting avanafil and related impurities thereof, ammonium formate-acetonitrile is taken as a mobile phase, and avanafil is analyzed and identified by adopting an analysis method of UPLC (Ultra Performance Liquid Chromatography) compatible with LC-MS (Liquid Chromatography-Mass Spectrometry), so that avanafil synthesized by adopting a specific synthesis route and related impurities thereof can be effectively separated; and a new method is provided for key process parameter control and quality control of the avanafil bulk drug.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting avanafil and its related impurities. Background technique [0002] Avanafil (Avanafil), is an oral rapid-acting highly selective phosphodiesterase-5 (PDE-5) inhibitor, which was launched in the United States in 2012 and is used for the treatment of male erectile dysfunction. For the medicine obtained by the total synthesis method, due to the use of various intermediates and the use of many reaction reagents, when the desired final active pharmaceutical ingredient (API) is obtained, pharmaceutical impurities will be mixed in the API. These impurities can have a significant impact on the effectiveness and safety of the final product. According to the general guidelines on impurities in drug substances recommended by the International Conference on Harmonization (ICH), any impurity greater than 0.10% in the drug substance should be identified and charac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 孙允凯赵梦梦喻芳芳李海龙陈永黎航
Owner HARVEST PHARMA HUNAN CO LTD
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