A kind of impurity detection method of ingaverine and preparation thereof

A detection method, the technology of ingavirin, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as difficult to evaluate the quality of ingavirin ingavirin capsules, less monitoring of important impurities, etc., to achieve accurate Quality control method, low cost, scientific detection method effect

Active Publication Date: 2018-06-26
JIANGSU CHIA TAI FENGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the prior art, there are few introductions to the quality control of Ingaverin and Ingaverin Capsules, less monitoring of important impurities, and it is difficult to evaluate the quality of Ingaverin, especially Ingaverin Capsules.

Method used

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  • A kind of impurity detection method of ingaverine and preparation thereof
  • A kind of impurity detection method of ingaverine and preparation thereof
  • A kind of impurity detection method of ingaverine and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 High Performance Liquid Chromatography Determination of Impurities in Ingaverine

[0038] Instrument and equipment samples:

[0039] Detector: UV detector, the detection wavelength is 214nm;

[0040] Chromatographic column: Octadecylsilane bonded silica gel (Thermo Syncronis C 18 , 4.6×250mm, 5μm applicable)

[0041] Column temperature: 35°C;

[0042] Mobile phase: the organic phase is a phosphate buffer at pH=2.6; the aqueous phase is methanol;

[0043] Mobile phase flow rate: 1.5ml / min

[0044] Carry out gradient elution according to the following table, elution conditions:

[0045]

[0046] Detection steps: take an appropriate amount of ingaverin, accurately weighed, add the initial mobile phase to dissolve and quantitatively dilute to make a solution containing about 1.0 mg of ingaverin per 1 ml, as the test solution; accurately pipette the test product Put 1ml of the solution in a 100ml measuring bottle, add the initial mobile phase and dilute...

Embodiment 2

[0050] Embodiment 2 Determination of impurities in ingaverine by high performance liquid chromatography

[0051] Instrument and equipment samples:

[0052] Detector: UV detector, the detection wavelength is 210nm;

[0053] Chromatographic column: Octadecylsilane bonded silica gel (Thermo Syncronis C 18 , 4.6×250mm, 5μm applicable)

[0054] Column temperature: 30°C;

[0055] Mobile phase: the organic phase is a phosphate buffer at pH=2.0; the aqueous phase is methanol;

[0056] Mobile phase flow rate: 1.5ml / min

[0057] Carry out gradient elution according to the following table, elution conditions:

[0058]

[0059] Assay steps are the same as in Example 1, and the test results are shown in Table 2.

[0060] The degree of separation between the impurities of table 2 embodiment 2

[0061] Peak order

Embodiment 3

[0062] Embodiment 3 High-performance liquid chromatography measures impurities in Ingaverine Capsules

[0063] Instrument and equipment samples:

[0064] Detector: UV detector, the detection wavelength is 214nm;

[0065] Chromatographic column: Octadecylsilane bonded silica gel (Thermo Syncronis C 18 , 4.6×250mm, 5μm applicable)

[0066] Column temperature: 50°C;

[0067] Mobile phase: the organic phase is a phosphate buffer at pH=3.0; the aqueous phase is methanol;

[0068] Mobile phase flow rate: 0.5ml / min

[0069] Carry out gradient elution according to the following table, elution conditions:

[0070]

[0071]Detection steps: Take an appropriate amount of the content of this product under the item of loading difference, add appropriate amount of water to dissolve ingaverin, and quantitatively dilute to make a solution containing about 1mg of ingaverin per 1ml, shake well, filter, and take Continue filtrate as need testing solution; Accurately pipette need testing ...

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Abstract

The invention provides ingavrin and a method for detecting impurity of an ingavrin preparation. The method is a high-performance liquid chromatography, takes octadecylsilane chemically bonded silica or octa-silane chemically bonded silica as a chromatographic column of a filler, takes a mixed solvent of an organic phase and a water phase as a mobile phase for gradient elution, and ten impurities in ingavrin and its preparation can be determined. The method has the advantages of low process and low cost, by employing a gradient elution method, ten impurities in ingavrin and its preparation can be effectively determined and separated, the detection method is scientific, reasonable and objective, so that the ingavrin quality can be better controlled.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to an impurity detection method of the immunomodulator ingavirin and its preparation. Background technique [0002] Ingavirin (5-{[2-(1H-imidazol-4-yl)ethyl]amino}-5-oxoylpentanoic acid) is an antiviral infection and immunomodulator, and its molecular formula is C 10 h 15 N 3 o 3 , molecular weight 225.24, structural formula: [0003] [0004] Ingavirin is a new antiviral product launched by Valenta, one of the largest pharmaceutical companies in Russia. Antiviral efficacy. The mechanism of action of ingavirin is to inhibit the migration of newly synthesized viral NP protein from the cytoplasm to the nucleus, thereby inhibiting viral nuclear replication, which is an important stage for the virus to infect the host. In June 2009, the Russian Ministry of Health and Social Development issued a circular, including ingaverine as the recommended drug for the treatment of influenza A ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 赵亚男李家庆杜柳辉杨杨朱永强
Owner JIANGSU CHIA TAI FENGHAI PHARMA
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