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A method for detecting related substances of velpatasvir

A technology of related substances and detection methods, which is applied in the field of detection of velpatasvir related substances, can solve problems such as methods for the determination of velpatasvir related substances that have not been seen, and achieve good resolution, effective separation, and good reproducibility sexual effect

Active Publication Date: 2020-11-03
ANHUI YELLEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] So far, there is no method reported in the literature for the determination of related substances of velpatasvir

Method used

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  • A method for detecting related substances of velpatasvir
  • A method for detecting related substances of velpatasvir
  • A method for detecting related substances of velpatasvir

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The test solution: take an appropriate amount of velpatasvir raw drug powder, dissolve it with methanol and quantitatively dilute it to a solution of 1.0 mg / mL;

[0037] Mobile phase A: 0.1% phosphoric acid aqueous solution;

[0038] Mobile phase B: acetonitrile;

[0039] Chromatographic column: 250mm×4.6mm, 5μm;

[0040] Filler: C 18 Alkylsilane bonded silica gel;

[0041] Column brand: Kromstar

[0042] Column temperature: 30°C;

[0043] Detection wavelength: 295nm;

[0044] Flow rate: 1.2mL / min;

[0045] Elution method: gradient elution;

[0046] Gradient elution conditions:

[0047]

[0048] Take 20 μl of the above-mentioned test solution, inject it into a high-performance liquid chromatograph, and record the chromatogram.

[0049] see results figure 1 , figure 1 The chromatographic peak at 14.330min is the chromatographic peak of velpatasvir related substance A, and the chromatographic peak at 14.774min is the chromatographic peak of velpatasvir. The...

Embodiment 2

[0051] The test solution: take an appropriate amount of velpatasvir raw drug powder, dissolve it with methanol and quantitatively dilute it to a solution of 1.0 mg / mL;

[0052] Mobile phase A: 0.1% phosphoric acid aqueous solution;

[0053] Mobile phase B: acetonitrile;

[0054] Chromatographic column: 250mm×4.6mm, 5μm;

[0055] Filler: C 18 Alkylsilane bonded silica gel;

[0056] Column brand: Agilent

[0057] Column temperature: 30°C;

[0058] Detection wavelength: 295nm;

[0059] Flow rate: 1.2mL / min;

[0060] Elution method: Gradient elution

[0061] Gradient elution conditions:

[0062]

[0063] Take 20 μl of the above-mentioned test solution, inject it into a high-performance liquid chromatograph, and record the chromatogram.

[0064] see results figure 2 , figure 2 The chromatographic peak at 12.450min is the chromatographic peak of velpatasvir related substance A, and the chromatographic peak at 12.925min is the chromatographic peak of velpatasvir. The...

Embodiment 3

[0065] Embodiment 3 Comparative Examples.

[0066] Take the sample in Example 1, and replace the mobile phase A in Example 1 with 0.1% trifluoroacetic acid aqueous solution for detection, and other chromatographic parameters are the same as in Example 1. The result is as image 3 As shown, and try to investigate different gradient elution conditions under this system, the results can not separate velpatasvir and its related substance A, showing that the main peak can not be separated from the main peak with the organic solvent acetonitrile as the mobile phase with trifluoroacetic acid aqueous solution and organic solvent acetonitrile The impurities are effectively separated, which is not suitable for the detection of related substances of velpatasvir.

[0067] In summary, the method for related substances of velpatasvir described in the present invention can be applied to the control of related substances of velpatasvir.

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Abstract

The invention relates to a method for detecting velpatasvir related substances. Gradient elution can be carried out by taking a phosphoric acid aqueous solution and acetonitrile as mobile phases, andvelpatasvir can be effectively separated from the related substances.

Description

technical field [0001] The invention relates to a method for detecting related substances of velpatasvir, belonging to the technical field of drug analysis. Background technique [0002] The third generation of Gilead is also known as Jisandai and Icolusa, and its trade name is Epclusa. It is a compound preparation of Sofosbuvir and Velpatasvir. It is suitable for the treatment of all six genotypes of hepatitis C patients. The German company successfully developed it and was approved to go on the market in the United States on June 28, 2016. [0003] Velpatasvir, also known as Methyl[(2S)-1-[(2S,5S)-2-[9-[2-[(2S,4S)-1-[(2R)-2-[ (methoxycarbonyl)amino]-2-phenylacetyl]-4-(methoxymethyl)pyrrolidin-2-yl]-1H-imidazol-5-yl]-1,11-dihydroisochromeno[4',3':6,7]naphtho[ 1,2-d]imidazol-2-yl]-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate, the chemical structure is shown in the following formula I, according to the current process route, There is process impurity A in th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 蔡惠坚顾世海
Owner ANHUI YELLEN PHARMA
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