CN104914185B - A kind of Favipiravir has the HPLC assay method of related substance - Google Patents
A kind of Favipiravir has the HPLC assay method of related substance Download PDFInfo
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Abstract
A kind of Favipiravir has the HPLC assay method of related substance.The invention discloses the relevant substance detecting method of a kind of Favipiravir, specifically use diode array detector, with acetonitrile (mobile phase A) phosphate solution (Mobile phase B) for flowing phase.Take Favipiravir and the related preparations containing Favipiravir is appropriate, add flowing and be configured to the mg solution Han Favipiravir 0.2 in every 1 ml mutually, as need testing solution.And become containing about 2 g solution in every 1 ml with flowing phase dilution, as contrast solution.Respectively sample introduction, in need testing solution chromatogram each impurity peak area and the main peak area that cannot be greater than contrast solution.Favipiravir of the present invention and the relevant substance detecting method of the related preparations containing Favipiravir, can detect impurity and the catabolite situation of Favipiravir fast and accurately.Simple to operation, highly sensitive, can preferably control product quality.
Description
Technical field
The present invention relates to a kind of Favipiravir and the relevant substance detecting method of the related preparations containing Favipiravir, belong to medicine
Thing analyzes detection field.
Background technology
Favipiravir is a kind for the treatment of of influenza medicine, has different mechanism of action from a lot of Tamiflu.Oseltamivir phosphate capsule etc.
Medicine is that the virus bred by prevention gets into extracellular, to prevent infection from increasing the weight of；And Favipiravir is by block cell
Gene replication, thus contain virus itself propagation.Owing to influenza virus is similar with Ebola virus, it is all RNA viruses, so
Favipiravir likely hinders Ebola virus at cellular proliferative, thus contains infection.Owing to Favipiravir is in building-up process
In likely introduce retained material and other is about material, it is also possible to produce catabolite, the present invention couple in storage
Favipiravir carries out purity analysis, uses common chromatographic column (C18Chromatographic column) measure the relevant thing of Favipiravir rapidly and accurately
Matter, it is ensured that Favipiravir quality controllable, has important practical significance in terms of the quality control of synthesis and production process.
Not yet retrieving Favipiravir has the HPLC assay method of related substance at present.Favipiravir of the present invention and being correlated with containing Favipiravir
The relevant substance detecting method of preparation, can detect impurity and the catabolite situation of Favipiravir, operation letter fast and accurately
Victory, highly sensitive, can preferably control product quality.
Summary of the invention
It is an object of the invention to provide and a kind of use diode array detector to Favipiravir and containing Favipiravir
Related preparations carries out the assay method of Related substances separation.
In Favipiravir of the present invention, the realization of Related substances separation method comprises the following steps:
(1) chromatographic condition: detector uses diode array detector, column temperature 30 DEG C, flow velocity 1.0ml/min；Chromatostrip
The flowing of part is made up of acetonitrile (mobile phase A)-phosphate solution (Mobile phase B)；Wherein phosphate solution (Mobile phase B), dense
Degree scope 0.005～0.015mol/L, adjusts pH scope 6.0～8.0, and its optium concentration is 0.01mol/L, and optimal pH is about
7.0；Theoretical cam curve is calculated by Favipiravir peak and is not less than 3000.
(2) preparation of need testing solution: take Favipiravir or the related preparations containing Favipiravir is appropriate, add flowing and prepare mutually
Become 0.2mg/ml solution, as need testing solution.
(3) preparation of contrast solution: it is appropriate to measure above-mentioned (2) need testing solution, add flowing phase dilution become in every 1ml containing about
2 μ g solution, as contrast solution.
(4) assay method: take contrast solution 10 μ l and inject chromatograph of liquid, regulate detection sensitivity, make main constituent chromatograph
Peak height is about the 20% of full scale, then takes need testing solution 10 μ l injection chromatograph of liquid, and record chromatogram is to Favipiravir master
5 times of peak retention time, if any impurity peaks in need testing solution chromatogram, measure the sum of each impurity peak area, and it is right to cannot be greater than
According to the peak area (see Fig. 1, Fig. 2) of main peak in solution.
A kind of Favipiravir of the present invention has the HPLC assay method of related substance, the preparation of need testing solution in above-mentioned (2):
For meeting the needs of need testing solution detectable concentration, taking Favipiravir appropriate, being configured to concentration mutually with flowing is that every 1ml contains
0.2mg solution, as need testing solution.The solution of a series of variable concentrations is become the most respectively, respectively sample introduction 10 μ with flowing phase dilution
L, is allowed to produce the signal that main peak is baseline noise 3 times.Through test, detectability is 0.2ng (S/N >=3), if with relevant thing
Concentration 0.2mg/ml when quality inspection is looked into calculates, and its limit of detection is 0.1%.
A kind of Favipiravir of the present invention has the HPLC assay method of related substance, the preparation of contrast solution in above-mentioned (3): essence
Close measure above-mentioned need testing solution 1ml, insert 100ml measuring bottle, add flowing phased soln and be diluted to scale, as contrast solution.
When this contrast solution concentration range is in 1～10 μ g/ml, peak area and concentration are good linear relationship, its linear correlation
Coefficient is 0.9996 (see Fig. 3).
Having the HPLC assay method of related substance in a kind of Favipiravir of the present invention, it has related substance to detect HPLC chromatogram
In, occur if any impurity peaks, measure the sum of each impurity peak area, the main peak area (1%) of contrast solution should be cannot be greater than.
A kind of Favipiravir of the present invention has the HPLC assay method of related substance, it is adaptable to various needs carry out there is related substance
The Favipiravir of detection and containing the related preparations of Favipiravir, as tablet, capsule, granule, injection, controlled release ease up controlled release
And the compound preparation of various Favipiravir.
The present invention having the active effect that compared with the prior art
1. the present invention uses diode array detector to have related substance to detect this product, establishes a kind of quicklook
The effective ways evaluating chromatographic peak purity: can judge the purity of chromatographic peak intuitively, and judge to exist the position of Interference Peaks, energy
Enough whole spectral informations obtaining " at stream ", quickly obtain the absorption spectrum of chromatographic component, and diode array detector is more general
UV-visible detector, advantage is that the retention time that can not only rely on chromatograph carries out qualitative, and can provide according to it
Spectral information carries out qualitative, substantially increases credibility qualitatively, and is effectively increased its detection sensitivity.
2. a kind of Favipiravir of the present invention has the HPLC assay method of related substance, can detect that method is drawn rapidly and accurately
The impurity of Wei and catabolite situation, can preferably control product quality.
3. the present invention is applicable to the Favipiravir of various dosage form and containing the related preparations of Favipiravir, as tablet, capsule,
Granule, injection, controlled release ease up controlled release and the compound preparation of various Favipiravir..
4. detection method is accurate, simple to operation, and favorable reproducibility is highly sensitive, can fully meet and have related substance
Check the requirement measured with catabolite, preferably control the special impurities in sample, it is ensured that product quality, practical at work
Property is strong.
Accompanying drawing explanation
The HPLC collection of illustrative plates of Fig. 1 contrast solution
The HPLC collection of illustrative plates of Fig. 2 need testing solution
Fig. 3 Favipiravir limit of impurities linear relationship chart
Detailed description of the invention
Embodiment 1
1 chromatographic condition and system suitability
The selection of 1.1 chromatographic conditions
Instrument: Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5, its optimum column temperature 30 DEG C, flow velocity 1.0ml/
min.Liquid-phase chromatographic column octadecylsilane chemically bonded silica is filler (250mm × 4.6mm, 5 μm), with reference to pertinent literature also
Binding tests concrete condition, successively selects methanol-water, acetonitrile-water, methanol-acetonitrile-water, methanol-acetonitrile-phosphate solution etc.
Multiple condition, finally determines that flowing is made up of acetonitrile (mobile phase A)-phosphate solution (Mobile phase B), wherein phosphate solution
(Mobile phase B), concentration range 0.005～0.015mmol/L, adjust pH scope 6.0～8.0, its optium concentration is 0.01mol/
L, optimal pH is about 7.0, carries out gradient elution by table 1.Sample size 10 μ l.
Table 1 gradient elution program
Under this chromatographic condition, Favipiravir main peak retention time is moderate, and peak shape is preferable.
1.2 sensitivity determination
Taking Favipiravir reference substance appropriate, being configured to concentration mutually with flowing is every 1ml solution Han 0.2mg, more respectively with stream
Dynamic phase dilution becomes the solution of a series of variable concentrations, and sample introduction 10 μ l, is allowed to produce the signal that main peak is baseline noise three times respectively.
Through test, detectability is 0.2ng (S/N >=3), if calculating with concentration 0.2mg/ml during Related substances separation, and its detection
Limit is 0.1%.Result shows, this method is highly sensitive, can fully meet the requirement that Related substances separation measures.
1.3 stability of solution
Take with a need testing solution, respectively at 0,2,6,10,24h respectively sample introductions measure, its main peak peak area and relevant
Substance-measuring result is basicly stable in 24h.
Above result of the test shows, the method simplicity is sensitive, favorable reproducibility, can be preferably to the matter of Favipiravir in sample
Amount preferably detects.
The preparation of 2 need testing solutions:
Take Favipiravir or the related preparations containing Favipiravir is appropriate, add flowing and be configured to 0.2mg/ml solution mutually, as
Need testing solution.
The preparation of 3 contrast solutions:
Measure above-mentioned (2) need testing solution appropriate, add flowing phase dilution and become containing about 2 μ g solution in every 1ml, molten as comparison
Liquid.
4 Favipiravirs and have the detection of related substance containing the related preparations of Favipiravir:
Take contrast solution 10 μ l and inject chromatograph of liquid, regulate detection sensitivity, make main constituent chromatograph peak height be about full amount
The 20% of journey, then take need testing solution 10 μ l injection chromatograph of liquid, record chromatogram is to the 5 of Favipiravir main peak retention time
Times, if any impurity peaks in need testing solution chromatogram, measure the sum of each impurity peak area, cannot be greater than main peak in contrast solution
Peak area.
Embodiment 2 Favipiravir sheet has the mensuration of related substance
Taking this product 20, accurately weighed, finely ground, precision weighs and (is approximately equivalent to Favipiravir 2mg) in right amount, adds flowing and matches
Make the solution Han 0.2mg in every 1ml, filter, take filtrate as need testing solution；It is appropriate that precision measures need testing solution, adds stream
Dynamic phase dilution becomes containing about 2 μ g solution in every 1ml, as contrast solution.Under following selected chromatographic condition: diode array is examined
Survey device (Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5), be filler with octadecylsilane chemically bonded silica,
Flowing is made up of acetonitrile (mobile phase A)-phosphate solution (Mobile phase B), wherein phosphate solution (Mobile phase B), concentration model
Enclosing 0.005～0.015mol/L, adjust pH scope 6.0～8.0, its optium concentration is 0.01mol/L, and optimal pH is about 7.0.
Chromatogram column temperature is 30 DEG C, flow velocity 1.0ml/min.Gradient elution is carried out by table 1 program.
Theoretical cam curve is calculated by Favipiravir peak should be not less than 3000.Take reference substance solution 10 μ l and inject liquid chromatograph
Instrument, regulates detection sensitivity, makes contrast solution main peak height be about the 20% of full scale, then take each 10 μ l of need testing solution, respectively
Inject chromatograph of liquid, 5 times of record chromatogram to main constituent peak retention time.If any impurity in need testing solution chromatogram
Peak, measures the sum of each impurity peak area, cannot be greater than the main peak area of contrast solution.Measurement result is shown in Table 2.
Table 2 Favipiravir sheet relevant substance-measuring result
Embodiment 3 Favipiravir capsule has the mensuration of related substance
Taking this product content appropriate, finely ground, precision weighs fine powder (being approximately equivalent to Favipiravir 2mg), adds flowing and prepares mutually
Become the solution Han 0.2mg in every 1ml, filter, take filtrate as need testing solution.It is appropriate that precision measures need testing solution, adds flowing
Phase dilution becomes containing about 2 μ g solution in every 1ml, as contrast solution.Under following selected chromatographic condition: photodiode array detection
Device (Shimadzu: LC-20AT, SPD-M20A, SIL-20A, DGU-20A5), is filler with octadecylsilane chemically bonded silica, stream
Move and be made up of acetonitrile (mobile phase A)-phosphate solution (Mobile phase B), wherein phosphate solution (Mobile phase B), concentration range
0.005～0.015mol/L, adjust pH scope 6.0～8.0, its optium concentration is 0.01mol/L, and optimal pH is about 7.0.Color
Spectrum column temperature is 30 DEG C, flow velocity 1.0ml/min.Gradient elution is carried out by table 1 program.
Theoretical cam curve is calculated by Favipiravir peak should be not less than 3000.Take contrast solution 10 μ l and inject chromatograph of liquid,
Regulation detection sensitivity, makes contrast solution main peak height be about the 20% of full scale, then takes each 10 μ l of need testing solution, be injected separately into
Chromatograph of liquid, 5 times of record chromatogram to main constituent peak retention time.If any impurity peaks in need testing solution chromatogram, amount
Take the sum of each impurity peak area, cannot be greater than the main peak area of contrast solution.Measurement result is shown in Table 3.
Table 3 Favipiravir capsule relevant substance-measuring result
Embodiment 4 Favipiravir slow releasing tablet has the mensuration of related substance
Taking this product appropriate, finely ground, precision weighs fine powder (being approximately equivalent to Favipiravir 2mg), adds flowing and is configured to every 1ml mutually
In the solution Han 0.2mg, filter, take filtrate as need testing solution.It is appropriate that precision measures need testing solution, adds flowing phase dilution and becomes
Containing about 2 μ g solution in every 1ml, as contrast solution.Under following selected chromatographic condition: diode array detector (Shimadzu:
LC-20AT, SPD-M20A, SIL-20A, DGU-20A5), it is filler with octadecylsilane chemically bonded silica, flowing is by second
Nitrile (mobile phase A)-phosphate solution (Mobile phase B) composition, wherein phosphate solution (Mobile phase B), concentration range 0.005～
0.015mol/L, adjusts pH scope 6.0～8.0, and its optium concentration is 0.01mol/L, and optimal pH is about 7.0.Chromatographic column temperature
Degree is 30 DEG C, flow velocity 1.0ml/min.Gradient elution is carried out by table 1 program.
Theoretical cam curve is calculated by Favipiravir peak should be not less than 3000.Take contrast solution 10 μ l and inject chromatograph of liquid,
Regulation detection sensitivity, makes contrast solution main peak height be about the 20% of full scale, then takes each 10 μ l of need testing solution, be injected separately into
Chromatograph of liquid, 5 times of record chromatogram to main constituent peak retention time.If any impurity peaks in need testing solution chromatogram, amount
Take the sum of each impurity peak area, cannot be greater than the main peak area of contrast solution.Measurement result is shown in Table 4.
Table 4 Favipiravir slow releasing tablet relevant substance-measuring result
Claims (4)
1. a Favipiravir has the HPLC assay method of related substance, it is characterised in that: detector uses diode array inspection
Survey device；The flowing of chromatographic condition is made up of mobile phase A acetonitrile and Mobile phase B phosphate solution, and wherein Mobile phase B phosphate is molten
The concentration range of liquid is 0.005～0.015mol/L, and pH scope is 6.0～8.0, and chromatogram column temperature is 30 DEG C, flow velocity 1.0ml/
Min, gradient elution program such as following table:
Detection method comprises the following steps:
(1) chromatographic condition:
Employing octadecylsilane chemically bonded silica is filler, and with acetonitrile-phosphate solution for flowing phase, flow velocity is 1.0ml/
Min, theoretical cam curve is calculated by Favipiravir and is not less than 3000；
(2) preparation of need testing solution:
Take Favipiravir or the related preparations containing Favipiravir is appropriate, add flowing and be configured to 0.2mg/ml solution mutually, as examination
Product solution；
(3) preparation of contrast solution:
Measure above-mentioned (2) need testing solution appropriate, add flowing phase dilution and become containing about 2 μ g solution in every 1ml, as contrast solution；
(4) assay method:
Take contrast solution 10 μ l and inject chromatograph of liquid, regulate detection sensitivity, make main constituent chromatograph peak height be about full scale
20%, then take need testing solution 10 μ l injection chromatograph of liquid, 5 times of record chromatogram to Favipiravir main peak retention time,
If any impurity peaks in need testing solution chromatogram, measure the sum of each impurity peak area, cannot be greater than the peak of main peak in contrast solution
Area.
A kind of Favipiravir the most according to claim 1 has the HPLC assay method of related substance, it is characterised in that: flowing
The optium concentration of phase B phosphate solution is 0.01mol/L, and optimal pH is 7.0.
A kind of Favipiravir the most according to claim 1 has the HPLC assay method of related substance, it is characterised in that: wherein
(3) preparation of contrast solution: take Favipiravir related preparations appropriate, adds flowing and is configured to 0.2mg/ml solution mutually, as examination
Product solution；Precision measures need testing solution 1ml again, inserts 100ml measuring bottle, adds flowing phased soln and is diluted to scale, as right
According to solution.
4. according to described a kind of Favipiravir arbitrary in claims 1 to 3 has the HPLC assay method of related substance, its feature
It is: the method is applicable to the Favipiravir that various needs carry out having related substance to detect and the related preparations containing Favipiravir.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106588786B (en) * | 2015-10-14 | 2019-03-08 | 山东省药学科学院 | A kind of preparation method of high-purity Favipiravir impurity |
| CN105717230B (en) * | 2016-02-16 | 2017-09-12 | 山东省药学科学院 | A kind of method of organic solvent residual in detection Favipiravir |
| CN117517529A (en) * | 2020-02-07 | 2024-02-06 | 北京四环制药有限公司 | Method for detecting fapirrevir and related substances thereof by HPLC and application of method |
| CN112730653A (en) * | 2020-12-18 | 2021-04-30 | 苏州海科医药技术有限公司 | Method for detecting concentration of Favipiravir in clinical research plasma sample |
| CN113155985A (en) * | 2020-12-19 | 2021-07-23 | 浙江华海药业股份有限公司 | Analysis and detection method of Favipiravir photodegradation product |
| CN112763622B (en) * | 2020-12-30 | 2023-02-07 | 南京杰运医药科技有限公司 | Method for determining plamavir through liquid chromatography |
| CN112649542B (en) * | 2021-01-14 | 2022-09-20 | 浙江海正药业股份有限公司 | Gas chromatography detection method for dicyclohexylamine in faviravir |
| CN112903838A (en) * | 2021-01-15 | 2021-06-04 | 浙江海正药业股份有限公司 | Method for determining related substances in Favilavir |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010087117A1 (en) * | 2009-01-28 | 2010-08-05 | 日本曹達株式会社 | Method for producing dichloropyrazine derivative |
| CN104288154A (en) * | 2014-09-29 | 2015-01-21 | 成都新恒创药业有限公司 | Favipiravir pharmaceutical composition containing different particle size ranges |
| CN104496917A (en) * | 2014-12-15 | 2015-04-08 | 南京华威医药科技开发有限公司 | Synthesis method of Favipiravir |
-
2015
- 2015-06-10 CN CN201510316808.5A patent/CN104914185B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010087117A1 (en) * | 2009-01-28 | 2010-08-05 | 日本曹達株式会社 | Method for producing dichloropyrazine derivative |
| CN104288154A (en) * | 2014-09-29 | 2015-01-21 | 成都新恒创药业有限公司 | Favipiravir pharmaceutical composition containing different particle size ranges |
| CN104496917A (en) * | 2014-12-15 | 2015-04-08 | 南京华威医药科技开发有限公司 | Synthesis method of Favipiravir |
Non-Patent Citations (4)
| Title |
|---|
| Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model;Lisa Oestereich et al.;《Antiviral Research》;20140226;第105卷;第17-21页 * |
| T-705 (favipiravir) and related compounds: Novel broad-spectrum inhibitors of RNA viral infections;Yousuke Furuta et al.;《Antiviral Research》;20090630;第82卷(第3期);第95-102页 * |
| 埃博拉疫苗和药物研究进展;朱祥 等;《病毒学报》;20150531;第31卷(第3期);第287-292页 * |
| 法匹拉韦的合成;王欢 等;《中国医药工业杂志》;20141231;第45卷(第11期);第1009-1012页 * |
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