CN109187824A - A kind of HPLC analytical method of posaconazole - Google Patents
A kind of HPLC analytical method of posaconazole Download PDFInfo
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- CN109187824A CN109187824A CN201811454176.9A CN201811454176A CN109187824A CN 109187824 A CN109187824 A CN 109187824A CN 201811454176 A CN201811454176 A CN 201811454176A CN 109187824 A CN109187824 A CN 109187824A
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- posaconazole
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
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Abstract
The present invention provides a kind of HPLC analytical methods of posaconazole, sample solution containing posaconazole is passed through in chromatographic column, using reversed-phase liquid chromatography external standard percentage method quantitative analysis, liquid phase chromatogram condition are as follows: chromatographic column: use octadecylsilane chemically bonded silica for packing material, specification 4.6*250mm, 3 μm；Mobile phase: volume proportion is the mobile phase A of 50:50-60:40 and the mixed solution of Mobile phase B, isocratic elution；Detection wavelength is 205nm~220nm；Flow velocity is 1.0~2.0ml/min；Column temperature is 25~35 DEG C；Sampling volume is 10~30 μ L.The high efficient liquid phase analysis method of posaconazole provided by the present invention have the advantages that it is practical it is reliable, stability is preferable, data reappearance is strong, the quality of the product can be efficiently controlled.
Description
Technical field
The present invention relates to Pharmaceutical Analysis technical fields, in particular to a kind of high performance liquid chromatography point of posaconazole
Analysis method.
Background technique
Posaconazole (posaconazole, trade name promise section fly, Noxafil) be new pyroles antifungal, by original
The research and development of Schering Plough company, oral administration mixed suspension in November, 2005 criticized in European Initial Public Offering, U.S. FDA in September, 2006 i5 days
Quasi- listing, China's in June, 2013 are ratified by CFDA.Posaconazole is anti-by inhibiting the biosynthesis of ergosterol to play it
Fungi activity, belongs to fat-soluble medicine, and high fat diet increases its absorption.It is clinically used for treating and preventing invasive infections with fungi, tool
Have the characteristics of efficient, less toxic and wide spectrum, the especially drug-fast bacteria to polyenoid class and other triazole type medicines, including to Cryptococcus,
The infection such as neoformans category, Mycotoruloides all have preferable clinical efficacy.
In order to guarantee the subsequent research and development of posaconazole and the quality of production, the quality to bulk pharmaceutical chemicals and its preparation is needed to control
System.Therefore, research obtains the detection method of related the material impurities inspection and assay of a kind of posaconazole, this is raw to medicine
Producing seems especially urgent for enterprise.In the prior art, generally use it is isocratic solve the problems, such as content, using gradient solve impurity
Problem, but because the change dramatically of gradient often occurs that experimental result stability is poor, and data deviation is larger.
In view of this, it is necessary to which the analysis method of content and its impurity content to posaconazole in the prior art gives
It improves, to solve the above problems.
Summary of the invention
The purpose of the present invention is to provide a kind of HPLC analytical methods of posaconazole, it can be accurate simultaneously
The content and impurity for determining posaconazole, can efficiently control the quality of the product.
For achieving the above object, the present invention provides a kind of HPLC analytical methods of posaconazole: will
Sample solution containing posaconazole is passed through in chromatographic column, described using reversed-phase liquid chromatography external standard percentage method quantitative analysis
Liquid phase chromatogram condition are as follows:
Chromatographic column: using octadecylsilane chemically bonded silica for packing material, specification 4.6*250mm, and 3 μm；
Mobile phase: volume proportion is the mobile phase A of 50:50-60:40 and the mixed solution of Mobile phase B, isocratic elution；
Detection wavelength is 205nm~220nm；
Flow velocity is 1.0~2.0ml/min；
Column temperature is 25~35 DEG C；
Sampling volume is 10~30 μ L.
In some embodiments, phosphoric acid, tetramethylammonium hydroxide, the quality proportioning of water are (2~10) in mobile phase A:
(5~20): (1000~2000), the volume proportion of water and acetonitrile is (50~200): (800~950) in the Mobile phase B.
In some embodiments, sample solution is made of the preparation containing posaconazole with diluent.
In some embodiments, diluent is made of (0.1%~0.3%) triethylamine with methanol, described (0.1%~
0.3%) volume proportion of triethylamine solution and methanol is 20:80~30:70.
In some embodiments, the volume proportion of 0.1% triethylamine solution and methanol is 25:75 in diluent.
In some embodiments, the preparation containing posaconazole is posaconazole raw material, posaconazole tablet, Bo Shakang
Azoles injection or oral posaconazole suspension.Preferably posaconazole tablet.
In some embodiments, Detection wavelength 215nm, flow velocity 1.7ml/min, column temperature are 30 DEG C, sampling volume
For 20 μ L.
Compared with prior art, the beneficial effects of the present invention are: the efficient liquid phase of posaconazole provided by the present invention point
Analysis method have the advantages that it is practical it is reliable, stability is preferable, data reappearance is strong, and can be efficiently separated from posaconazole
2 critical impurities out, i.e. impurity RRT0.88 and impurity RRT0.93, can efficiently control the quality of the product.
Detailed description of the invention
Fig. 1 is the high-efficient liquid phase chromatogram of the posaconazole raw material in the embodiment of the present invention one；
Fig. 2 is the high-efficient liquid phase chromatogram of the posaconazole formulations in the embodiment of the present invention two；
Fig. 3 is the high-efficient liquid phase chromatogram of the posaconazole blank auxiliary in the embodiment of the present invention one.
Specific embodiment
The present invention is described in detail for each embodiment shown in reference to the accompanying drawing, but it should be stated that, these
Embodiment is not limitation of the present invention, those of ordinary skill in the art according to these embodiments made by function, method,
Or equivalent transformation or substitution in structure, all belong to the scope of protection of the present invention within.
Embodiment one:
The HPLC analytical method for present embodiments providing a kind of posaconazole, for posaconazole material content
With the measurement of impurity.Liquid phase chromatogram condition are as follows:
Chromatographic column: YMC Pack C18, specification 4.6*250mm, 3 μm
Mobile phase: mobile phase A: Mobile phase B=55:45 (volume proportion), isocratic elution, phosphoric acid, tetramethyl in mobile phase A
Ammonium hydroxide, water quality proportioning be 6:9:2000, water in Mobile phase B, acetonitrile volume proportion be 150:850.
Detection wavelength is 215nm；
Flow velocity is 1.7ml/min；
30 DEG C of column temperature；
20 μ L of sampling volume；
Diluent: 0.1% triethylamine: methanol=25:75 (volume proportion).
Experimental procedure:
Solution is prepared:
Posaconazole raw material about 50mg is taken, it is accurately weighed, it is placed in 100ml volumetric flask, appropriate diluent is added to dissolve and dilute
It releases to scale, shakes up, as test solution.
Precision measures test solution 1ml, sets in 100ml measuring bottle, diluent is added to be diluted to scale, shake up, as impurity
Contrast solution.
Precision weighs posaconazole reference substance 50mg, sets in 100ml measuring bottle, adds diluent to scale, shakes up, as content
Reference substance solution.
Method precision measures test solution, impurity contrast solution and each 20 μ l of content reference substance solution according to the above analysis
Liquid chromatograph is injected, records liquid chromatogram, as shown in Figure 1.It is miscellaneous that its is calculated according to the Self-control method that correction factor is not added
Matter calculates its content according to external standard method.
The result shows that blank solvent does not interfere the content detection of posaconazole raw material, its defects inspecting is not interfered yet.Pool is husky
Each impurity can be separated efficiently in health azoles raw material, and separating degree is all larger than 1.5, and peak shape is good, and peak purity is good, theoretical tray
Number is greater than 3000, and tailing factor is complied with standard less than 1.5.
Analysis method provided by the invention, according to Chinese Pharmacopoeia 2015 editions, Method Of Accomplishment verifying, including system adaptive are tried
It tests, destructive testing, influence factor test, recovery test and serviceability test.By these verifyings, the present invention is provided
Analysis method it is practical reliable, stability is preferable.
Embodiment two:
The HPLC analytical method for present embodiments providing a kind of posaconazole contains for posaconazole sustained release tablets
The measurement of amount and impurity.Liquid phase chromatogram condition are as follows:
Chromatographic column: YMC Pack C18, specification 4.6*250mm, 3 μm.
Proportion of mobile phase are as follows: mobile phase A: Mobile phase B=55:45 (volume proportion), isocratic elution, phosphoric acid in mobile phase A,
Tetramethylammonium hydroxide, the quality proportioning of water are 6:9:2000, water in Mobile phase B, acetonitrile volume proportion be 150:850；
Detection wavelength is 215nm；
Flow velocity is 1.7ml/min；
30 DEG C of column temperature；
20 μ L of sampling volume；
Diluent: 0.1% triethylamine: methanol=25:75 (volume proportion).
Experimental procedure:
Solution is prepared:
Take posaconazole tablet appropriate, it is finely ground, it is accurately weighed (being equivalent to posaconazole 50mg), it is placed in 100ml volumetric flask
In, add appropriate diluent, 45 DEG C of ultrasounds 30 minutes, diluent are settled to scale, shake up, 3000RPM is centrifuged 5 minutes, takes supernatant
Liquid is filtered with 0.45 micron membrane filter, and subsequent filtrate is as test solution.
Precision measures test solution 1m l, sets in 100ml measuring bottle, diluent is added to be diluted to scale, shake up, as impurity
Contrast solution；It takes tablet blank auxiliary appropriate, is placed in 1000ml volumetric flask, add appropriate diluent, it is 45 DEG C of ultrasounds 30 minutes, dilute
It releases agent and is settled to scale, shake up, 3000RPM is centrifuged 5 minutes, supernatant is taken to be filtered with 0.45 micron membrane filter, and subsequent filtrate is as empty
White auxiliary material solution.
Precision weighs posaconazole reference substance 50mg, sets in 100ml measuring bottle, adds diluent to scale, shakes up, as content
Reference substance solution.
Precision measures test solution, impurity contrast solution and each 20 μ l of content reference substance solution and injects liquid chromatograph,
Liquid chromatogram is recorded, as shown in Figures 2 and 3.Its impurity is calculated according to the Self-control method that correction factor is not added, according to external standard
Method calculates its content.
The result shows that blank auxiliary solution does not interfere the content detection of posaconazole sustained release tablets, its impurity is not interfered to examine yet
It surveys.Each impurity can be separated efficiently in posaconazole sustained release tablets, and separating degree is all larger than 1.5, and peak shape is good, and peak purity is good
Good, theoretical cam curve is greater than 3000, and tailing factor is complied with standard less than 1.5.
Posaconazole sustained release tablets content results: it is equivalent to the 99.2% of labelled amount；Impurity result: impurity RRT0.88's contains
Amount is 0.14%, and the content of impurity RRT0.93 is 0.33%.Crucial impurity can Accurate Determining in posaconazole sustained release tablets
Out.Failure test is carried out to posaconazole sustained release tablets simultaneously, degradation impurity is also efficiently separated, and separating degree is greater than 1.5,
Main peak purity is preferable, and the present invention can be with the quality of effectively evaluating posaconazole sustained release tablets.
Analysis method provided by the invention, according to Chinese Pharmacopoeia 2015 editions, Method Of Accomplishment verifying, including system adaptive are tried
It tests, destructive testing, influence factor test, recovery test and serviceability test.By these verifyings, the present invention is provided
Analysis method it is practical reliable, stability is preferable.
Embodiment three:
The HPLC analytical method for present embodiments providing a kind of posaconazole, for posaconazole injection
The measurement of content and impurity.Liquid phase chromatogram condition are as follows:
Chromatographic column: YMC Pack C18, specification 4.6*250mm, 3 μm.
Proportion of mobile phase are as follows: mobile phase A: Mobile phase B=55:45 (volume proportion), isocratic elution, phosphoric acid in mobile phase A,
Tetramethylammonium hydroxide, the quality proportioning of water are 6:9:2000, and water in Mobile phase B: the volume proportion of acetonitrile is 150:850；
Detection wavelength is 215nm；
Flow velocity is 1.7ml/min；
30 DEG C of column temperature；
20 μ L of sampling volume；
Diluent: 0.1% triethylamine: methanol=25:75 (volume proportion).
Experimental procedure:
Solution is prepared:
Take posaconazole injection appropriate (being equivalent to posaconazole 50mg), precision measures, it is placed in 100ml volumetric flask,
Add appropriate diluent, 45 DEG C of ultrasounds 5 minutes, diluent are settled to scale, shake up, 3000RPM is centrifuged 5 minutes, supernatant is taken to use
The filtering of 0.45 micron membrane filter, subsequent filtrate is as test solution.
Precision measures test solution 1ml, sets in 100ml measuring bottle, diluent is added to be diluted to scale, shake up, as impurity
Contrast solution.
It takes injection blank auxiliary appropriate, is placed in 100ml volumetric flask, add appropriate diluent, it is 45 DEG C of ultrasounds 5 minutes, dilute
It releases agent and is settled to scale, shake up, 3000RPM is centrifuged 5 minutes, is filtered with 0.45 micron membrane filter, and subsequent filtrate is molten as blank auxiliary
Liquid.
Precision weighs posaconazole reference substance 50mg, sets in 100ml measuring bottle, adds diluent to scale, shakes up, as content
Reference substance solution.Precision measures test solution, impurity contrast solution and each 20 μ l of content reference substance solution and injects liquid chromatogram
Instrument records liquid chromatogram.Its impurity is calculated according to the Self-control method that correction factor is not added, it is calculated according to external standard method and contains
Amount.
The result shows that blank auxiliary does not interfere the content detection of posaconazole injection, its defects inspecting is not interfered yet.Pool
Each impurity can be separated efficiently in Saperconazole injection, and separating degree is all larger than 1.5, and peak shape is good, and peak purity is good, theoretical
The number of plates is greater than 3000, and tailing factor is complied with standard less than 1.5.
Example IV:
The HPLC analytical method for present embodiments providing a kind of posaconazole is suspended for oral posaconazole
The content of agent and the measurement of impurity.Liquid phase chromatogram condition are as follows:
Chromatographic column: YMC Pack C18, specification 4.6*250mm, 3 μm.
Proportion of mobile phase are as follows: mobile phase A: Mobile phase B=55:45 (volume proportion), isocratic elution, phosphoric acid in mobile phase A,
Tetramethylammonium hydroxide, the quality proportioning of water are 6:9:2000, and water in Mobile phase B: the volume proportion of acetonitrile is 150:850；
Detection wavelength is 215nm；
Flow velocity is 1.7ml/min；
30 DEG C of column temperature；
20 μ L of sampling volume；
Diluent: 0.1% triethylamine: methanol=25:75 (volume proportion).
Experimental procedure:
Solution is prepared:
Take oral posaconazole suspension appropriate (being equivalent to posaconazole 50mg), precision measures, and is placed in 100ml volumetric flask
In, add appropriate diluent, 45 DEG C ultrasound 5 minutes, diluent is settled to scale, shakes up.3000RPM is centrifuged 5 minutes, takes supernatant
It is filtered with 0.45 micron membrane filter, subsequent filtrate is as test solution.
Precision measures test solution 1m l, sets in 100ml measuring bottle, diluent is added to be diluted to scale, shake up, as impurity
Contrast solution.
It takes tablet blank auxiliary appropriate, is placed in 100ml volumetric flask, add appropriate diluent, 45 DEG C of ultrasounds 5 minutes, dilution
Agent is settled to scale, shakes up, and 3000RPM is centrifuged 5 minutes, is filtered with 0.45 micron membrane filter, and subsequent filtrate is as blank auxiliary solution.
Precision weighs posaconazole reference substance 50mg, sets in 100ml measuring bottle, adds diluent to scale, shakes up, as content
Reference substance solution.
Precision measures test solution, impurity contrast solution and each 20 μ l of content reference substance solution and injects liquid chromatograph,
Record liquid chromatogram.Its impurity is calculated according to the Self-control method that correction factor is not added, calculates its content according to external standard method.
The result shows that blank auxiliary solution does not interfere the content detection of oral posaconazole suspension, do not interfere its miscellaneous yet
Quality detection.Each impurity can be separated efficiently in oral posaconazole suspension, and separating degree is all larger than 1.5, and peak shape is good, peak
Purity is good, and theoretical cam curve is greater than 3000, and tailing factor is complied with standard less than 1.5.
The series of detailed descriptions listed above only for feasible embodiment of the invention specifically
Protection scope bright, that they are not intended to limit the invention, it is all without departing from equivalent implementations made by technical spirit of the present invention
Or change should all be included in the protection scope of the present invention.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie
In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims
Variation is included within the present invention.Any reference signs in the claims should not be construed as limiting the involved claims.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (8)
1. a kind of HPLC analytical method of posaconazole, which is characterized in that by the sample solution containing posaconazole
It is passed through in chromatographic column, using reversed-phase liquid chromatography external standard percentage method quantitative analysis, the liquid phase chromatogram condition are as follows:
Chromatographic column: using octadecylsilane chemically bonded silica for packing material, specification 4.6*250mm, and 3 μm；
Mobile phase: volume proportion is the mobile phase A of 50:50-60:40 and the mixed solution of Mobile phase B, isocratic elution；
Detection wavelength is 205nm~220nm；
Flow velocity is 1.0~2.0ml/min；
Column temperature is 25~35 DEG C；
Sampling volume is 10~30 μ L.
2. a kind of HPLC analytical method of posaconazole according to claim 1, which is characterized in that the stream
Phosphoric acid, tetramethylammonium hydroxide, the quality proportioning of water are (2~10): (5~20): (1000~2000), the stream in dynamic phase A
The volume proportion of water and acetonitrile is (50~200): (800~950) in dynamic phase B.
3. a kind of HPLC analytical method of posaconazole according to claim 2, which is characterized in that the sample
Product solution is made of the preparation containing posaconazole with diluent.
4. a kind of HPLC analytical method of posaconazole according to claim 3, which is characterized in that described dilute
It releases agent and is made of (0.1%~0.3%) triethylamine with methanol, the volume of (0.1%~0.3%) triethylamine solution and methanol
Proportion is 20:80~30:70.
5. a kind of HPLC analytical method of posaconazole according to claim 4, which is characterized in that described dilute
Releasing the volume proportion of 0.1% triethylamine solution and methanol in agent is 25:75.
6. a kind of HPLC analytical method of posaconazole according to claim 3, which is characterized in that described to contain
The preparation for having posaconazole is that posaconazole raw material, posaconazole tablet, posaconazole injection or oral posaconazole are mixed
Suspension.
7. a kind of HPLC analytical method of posaconazole according to claim 6, which is characterized in that described to contain
The preparation for having posaconazole is posaconazole tablet.
8. a kind of HPLC analytical method of posaconazole according to claim 1, which is characterized in that the inspection
Survey wavelength is 215nm, and flow velocity 1.7ml/min, column temperature is 30 DEG C, and sampling volume is 20 μ L.
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| CN112697945A (en) * | 2020-12-18 | 2021-04-23 | 卓和药业集团有限公司 | Method for analyzing content of posaconazole enteric-coated tablets |
| CN112697937A (en) * | 2020-12-18 | 2021-04-23 | 卓和药业集团有限公司 | Method for analyzing dissolution rate of posaconazole enteric-coated tablets |
| CN114264748A (en) * | 2021-12-27 | 2022-04-01 | 卓和药业集团股份有限公司 | Method for analyzing content uniformity of posaconazole enteric-coated tablets |
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