CN114264748A - Method for analyzing content uniformity of posaconazole enteric-coated tablets - Google Patents
Method for analyzing content uniformity of posaconazole enteric-coated tablets Download PDFInfo
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- CN114264748A CN114264748A CN202111616539.6A CN202111616539A CN114264748A CN 114264748 A CN114264748 A CN 114264748A CN 202111616539 A CN202111616539 A CN 202111616539A CN 114264748 A CN114264748 A CN 114264748A
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- RAGOYPUPXAKGKH-XAKZXMRKSA-N posaconazole Chemical compound O=C1N([C@H]([C@H](C)O)CC)N=CN1C1=CC=C(N2CCN(CC2)C=2C=CC(OC[C@H]3C[C@@](CN4N=CN=C4)(OC3)C=3C(=CC(F)=CC=3)F)=CC=2)C=C1 RAGOYPUPXAKGKH-XAKZXMRKSA-N 0.000 title claims abstract description 48
- 229960001589 posaconazole Drugs 0.000 title claims abstract description 48
- 239000002662 enteric coated tablet Substances 0.000 title claims abstract description 25
- 238000000034 method Methods 0.000 title claims abstract description 15
- 239000000243 solution Substances 0.000 claims abstract description 27
- 238000001514 detection method Methods 0.000 claims abstract description 12
- 239000012085 test solution Substances 0.000 claims abstract description 11
- 239000002253 acid Substances 0.000 claims abstract description 9
- 239000012490 blank solution Substances 0.000 claims abstract description 9
- 239000003960 organic solvent Substances 0.000 claims abstract description 8
- 239000012088 reference solution Substances 0.000 claims abstract description 6
- 238000004366 reverse phase liquid chromatography Methods 0.000 claims abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 6
- 238000010812 external standard method Methods 0.000 claims abstract description 5
- 238000010829 isocratic elution Methods 0.000 claims abstract description 4
- 238000004445 quantitative analysis Methods 0.000 claims abstract description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 39
- 239000013558 reference substance Substances 0.000 claims description 18
- 239000000523 sample Substances 0.000 claims description 12
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 6
- 238000007865 diluting Methods 0.000 claims description 6
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- 239000000706 filtrate Substances 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000012488 sample solution Substances 0.000 claims description 3
- 238000009210 therapy by ultrasound Methods 0.000 claims description 2
- 238000004458 analytical method Methods 0.000 abstract description 14
- 238000010790 dilution Methods 0.000 description 4
- 239000012895 dilution Substances 0.000 description 4
- 238000004128 high performance liquid chromatography Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 230000005526 G1 to G0 transition Effects 0.000 description 3
- 238000004811 liquid chromatography Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- VHVPQPYKVGDNFY-DFMJLFEVSA-N 2-[(2r)-butan-2-yl]-4-[4-[4-[4-[[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one Chemical class O=C1N([C@H](C)CC)N=CN1C1=CC=C(N2CCN(CC2)C=2C=CC(OC[C@@H]3O[C@](CN4N=CN=C4)(OC3)C=3C(=CC(Cl)=CC=3)Cl)=CC=2)C=C1 VHVPQPYKVGDNFY-DFMJLFEVSA-N 0.000 description 1
- 241000228212 Aspergillus Species 0.000 description 1
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 241001337994 Cryptococcus <scale insect> Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 206010061598 Immunodeficiency Diseases 0.000 description 1
- 208000029462 Immunodeficiency disease Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 229940124350 antibacterial drug Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000007813 immunodeficiency Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- -1 lso Species 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000003607 modifier Substances 0.000 description 1
- 238000005220 pharmaceutical analysis Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 150000003852 triazoles Chemical class 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
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Abstract
The invention provides an analysis method for content uniformity of posaconazole enteric-coated tablets, which comprises the following steps: s1, analyzing the solution to be detected by reversed phase liquid chromatography, wherein the chromatographic conditions are as follows: the chromatographic column adopts an SB-C18 chromatographic column, the mobile phase consists of water, an organic solvent and an acid regulator, and isocratic elution is set according to volume fraction; carrying out quantitative analysis by adopting an external standard method; wherein the volume ratio of the water to the organic solvent to the acid regulator in the mobile phase is 630-650:350-370: 1-3; s2, the solution to be tested comprises: blank solution, test solution and reference solution. The method for analyzing the content uniformity of the posaconazole enteric-coated tablets is simple to operate, high in accuracy, high in precision and good in stability; the device is suitable for large-batch detection and analysis, and the efficiency is greatly improved.
Description
Technical Field
The invention relates to the technical field of pharmaceutical analysis, in particular to an analysis method for content uniformity of posaconazole enteric-coated tablets.
Background
Posaconazole (Posaconazole) is a derivative of itraconazole, and belongs to a second-generation triazole antibacterial drug. It has good inhibitory activity against Candida and Cryptococcus fungi, and also has good in vitro inhibitory activity against Aspergillus, and is therefore commonly used for treating patients with increased risk of infection due to severe immunodeficiency.
Content uniformity is a key parameter for evaluating the quality of a medicine. Content uniformity is the amount of difference between the contents of each tablet. The current detection and analysis is a gradient method, the method is long in time consumption, and the preparation process of the test solution is also complicated.
In order to ensure the subsequent research and development and production quality of the posaconazole enteric-coated tablets, a method for accurately and efficiently analyzing the content uniformity of the posaconazole enteric-coated tablets is researched and developed, which is particularly important for pharmaceutical production enterprises. By looking up Chinese and foreign documents, patents and the like, the existing detection method for determining the content uniformity of the posaconazole enteric-coated tablets is relatively simple and single, and is not beneficial to the control of enterprises on the product quality, so that an analysis method for effectively determining the content uniformity of the posaconazole enteric-coated tablets is urgently needed.
Disclosure of Invention
The invention aims to disclose an analysis method for content uniformity of posaconazole enteric-coated tablets, which is simple to operate, high in accuracy, high in precision and good in stability; the device is suitable for large-batch detection and analysis, and the efficiency is greatly improved.
In order to achieve the purpose, the invention provides an analysis method for content uniformity of posaconazole enteric-coated tablets, which comprises the following steps:
s1, analyzing the solution to be detected by reversed phase liquid chromatography, wherein the chromatographic conditions are as follows: selecting SB-C18 chromatographic column as chromatographic column, wherein the mobile phase comprises water, organic solvent and acid regulator, and isocratic elution is set according to volume fraction; carrying out quantitative analysis by adopting an external standard method; wherein the volume ratio of the water to the organic solvent to the acid regulator in the mobile phase is 630-650:350-370: 1-3;
s2, the solution to be tested comprises:
a blank solution, wherein the blank solution is a methanol solution;
test solution: putting 1 posaconazole enteric-coated tablet in a volumetric flask, adding a proper amount of methanol, and performing ultrasonic treatment to dissolve and dilute the posaconazole enteric-coated tablet to a scale to prepare a solution with the concentration of 0.4 mg/ml; shaking, filtering, and collecting filtrate as test solution;
control solution: taking a proper amount of posaconazole reference substance, placing the posaconazole reference substance in a volumetric flask, adding methanol to dissolve the posaconazole reference substance, diluting the posaconazole reference substance to a scale, and quantitatively diluting the posaconazole reference substance to prepare a reference solution of 0.4 mg/ml.
Further, the organic solvent of the mobile phase is selected from one or more of methanol, acetonitrile and ethanol.
Further, the acid regulator of the mobile phase is selected from one of phosphoric acid and acetic acid or a mixture thereof.
Furthermore, the detection wavelength of the chromatographic column is 244-264 nm, the flow rate is 1.0-2.0mL/min, the column temperature is 45-55 ℃, and the sample injection amount is 5-15 muL.
Compared with the prior art, the invention has the beneficial effects that: the method is simple to operate, high in accuracy, high in precision and good in stability; the device is suitable for large-batch detection and analysis, and the efficiency is greatly improved.
Drawings
FIG. 1 is a chromatogram of a blank solution according to the present invention;
FIG. 2 is a chromatogram of a control solution according to the present invention;
FIG. 3 is a chromatogram of a sample solution according to the present invention.
Detailed Description
The present invention is described in detail below with reference to various embodiments, but it should be understood that these embodiments are not intended to limit the present invention, and those skilled in the art should be able to make functional, methodical, or structural equivalents or substitutions according to these embodiments without departing from the scope of the present invention.
In the present disclosure, the term "reverse phase liquid chromatography" refers to liquid chromatography in which the mobile phase is polar and the stationary phase is non-polar. The reversed phase chromatography is a liquid chromatography separation mode in which a surface nonpolar carrier is used as a stationary phase and a solvent with stronger polarity than the stationary phase is used as a mobile phase. The reversed phase chromatographic column is a chromatographic column which is filled by taking a carrier bonded with nonpolar groups as a filling agent.
In the present invention, the term "external standard method" refers to a method of quantifying the response signal of a control substance as compared with the response signal of a component to be measured in a sample by using a pure product of the component to be measured as the control substance.
In the present invention, the term "isocratic elution" refers to an elution pattern in which the composition and flow rate of a mobile phase are constant during an analysis cycle of a sample component.
In the present invention, the term "blank solution" refers to a solution which is measured under conditions completely identical to those used for measuring a sample in order to eliminate interference in a detection and analysis method by high performance liquid chromatography. The measurement result is called a "blank value" and should be subtracted from the measurement result of the sample, thereby improving the accuracy of the measurement.
In the present invention, the term "test solution" refers to a solution of a sample to be tested in a high performance liquid chromatography detection analysis method.
In the present invention, the term "control solution" is used to refer to a solution of a standard sample in a high performance liquid chromatography assay.
In the present invention, the term "mobile phase" refers to a substance that moves forward carrying a component to be measured during liquid chromatography.
In the present invention, the term "acid modifier" is a substance used to maintain or modify the acidity of the mobile phase.
The invention provides an analysis method for content uniformity of posaconazole enteric-coated tablets, which analyzes a solution to be detected by a reversed-phase liquid chromatography, and specifically adopts the following scheme.
The apparatus used was: shimadzu 20-A high performance liquid chromatograph; a chromatographic column: an Agilent Zorbax SB-C18 chromatographic column with specification of 20mm 4.6mm, 3.5 μm; the mobile phase is water-acetonitrile-phosphoric acid, and the volume ratio of the water-acetonitrile-phosphoric acid is preferably 640:360: 1.5. The flow rate is 1.5 ml/min; the column temperature is 50 ℃; the sample injection volume is 10 mu L;
preparing a solution to be detected:
blank solution: methanol solution.
Preparation of control solution (fresh to use): precisely weighing about 20mg of posaconazole as a reference substance, placing the reference substance in a 50ml volumetric flask, adding methanol to dissolve the posaconazole, and diluting the posaconazole with methanol to obtain a solution containing about 0.4mg of posaconazole in each 1ml of posaconazole as a reference substance solution.
Preparation of a test solution: taking 1 enteric-coated tablet of posaconazole, grinding, putting into a 250ml volumetric flask, adding methanol to dissolve and diluting with methanol to prepare a solution containing about 0.4mg of posaconazole in each 1ml, filtering, and taking a subsequent filtrate as a test solution.
Precisely sucking 10 μ l of each of the blank solution, the reference solution and the sample solution, injecting into a liquid chromatograph, and recording chromatograms as shown in FIGS. 1-3. And calculating the content of each posaconazole enteric-coated tablet by peak area according to an external standard method.
The content of the posaconazole enteric-coated tablet is (the peak area of posaconazole in a test solution is multiplied by the dilution factor of the test solution, the weighing sample amount of a reference substance, the concentration of the reference substance)/(the average peak area of posaconazole in the reference solution, the dilution factor of the reference solution, the marked amount of the test solution) multiplied by 100 percent
Wherein, the sample weighing amount of the reference substance is 20.12mg, and the dilution multiple is 50 times, so the concentration of the reference substance is 0.4008mg/ml, the peak area of the reference substance is 5130304, the peak area of posaconazole in the test sample is 5111907, the dilution multiple is 250 times, and the LC (labeled amount) of the posaconazole enteric-coated tablet is 100mg, so the content uniformity is 99.84%.
Content uniformity%
Wherein the retention time of the posaconazole peak of the control solution is 1.117min, the peak width is 0.278, and the theoretical plate number is 1027.
The results show that the blank solvent does not interfere with the content uniformity detection of posaconazole. In the chromatogram of the control solution, the peak shape is good and the peak purity is good. Compared with the content result, the method has no difference, and the method shows that the solution has good stability and good repeatability after verification, and the recovery rate meets the requirement.
In conclusion, the high performance liquid chromatography analysis method of the posaconazole enteric-coated tablet provided by the invention is suitable for large-scale detection, and the detection efficiency is greatly improved; secondly, the method has the advantages of simple operation, high accuracy, high precision and good stability.
The above list of details is only for the purpose of describing possible embodiments of the invention, and they are not intended to limit the scope of the invention, and all equivalent embodiments or modifications that do not depart from the spirit of the present invention are intended to be included within the scope of the present invention.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description of the embodiments is for clarity only, and those skilled in the art should make the description as a whole, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (4)
1. A method for analyzing content uniformity of posaconazole enteric-coated tablets is characterized by comprising the following steps:
s1, analyzing the solution to be detected by reversed phase liquid chromatography, wherein the chromatographic conditions are as follows: the chromatographic column adopts an SB-C18 chromatographic column, the mobile phase consists of water, an organic solvent and an acid regulator, and isocratic elution is set according to volume fraction; carrying out quantitative analysis by adopting an external standard method; wherein the volume ratio of the water to the organic solvent to the acid regulator in the mobile phase is 630-650:350-370: 1-3;
s2, the solution to be tested comprises:
a blank solution, wherein the blank solution is a methanol solution;
test solution: putting 1 posaconazole enteric-coated tablet in a volumetric flask, adding a proper amount of methanol, and performing ultrasonic treatment to dissolve and dilute the posaconazole enteric-coated tablet to a scale to prepare a solution with the concentration of 0.4 mg/ml; shaking, filtering, and collecting the filtrate as sample solution;
control solution: taking a proper amount of posaconazole reference substance, placing the posaconazole reference substance in a volumetric flask, adding methanol to dissolve the posaconazole reference substance, diluting the posaconazole reference substance to a scale, and quantitatively diluting the posaconazole reference substance to prepare a reference solution of 0.4 mg/ml.
2. The method for analyzing the content uniformity of the posaconazole enteric-coated tablets as claimed in claim 1, wherein the organic solvent of the mobile phase is selected from one or more of methanol, acetonitrile and ethanol.
3. The method for analyzing the content uniformity of the posaconazole enteric-coated tablets as claimed in claim 2, wherein the acid regulator of the mobile phase is selected from one of phosphoric acid and acetic acid or a mixture thereof.
4. The method for analyzing the content uniformity of the posaconazole enteric-coated tablets as claimed in claim 3, wherein the detection wavelength of the chromatographic column is 244-264 nm, the flow rate is 1.0-2.0mL/min, the column temperature is 45-55 ℃, and the sample injection amount is 5-15 μ L.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170027931A1 (en) * | 2014-04-11 | 2017-02-02 | Sinotherapeutics Inc. | Posaconazole pharmaceutical compositions and preparation methods, uses and pharmaceutical formulations thereof |
| CN109187824A (en) * | 2018-11-30 | 2019-01-11 | 无锡福祈制药有限公司 | A kind of HPLC analytical method of posaconazole |
| CN111638281A (en) * | 2020-05-28 | 2020-09-08 | 上海宣泰海门药业有限公司 | Analysis method of related substances of posaconazole enteric-coated tablets |
| CN111638280A (en) * | 2020-05-28 | 2020-09-08 | 上海宣泰海门药业有限公司 | Method for analyzing content of posaconazole enteric-coated tablets |
| 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 |
-
2021
- 2021-12-27 CN CN202111616539.6A patent/CN114264748A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170027931A1 (en) * | 2014-04-11 | 2017-02-02 | Sinotherapeutics Inc. | Posaconazole pharmaceutical compositions and preparation methods, uses and pharmaceutical formulations thereof |
| CN109187824A (en) * | 2018-11-30 | 2019-01-11 | 无锡福祈制药有限公司 | A kind of HPLC analytical method of posaconazole |
| CN111638281A (en) * | 2020-05-28 | 2020-09-08 | 上海宣泰海门药业有限公司 | Analysis method of related substances of posaconazole enteric-coated tablets |
| CN111638280A (en) * | 2020-05-28 | 2020-09-08 | 上海宣泰海门药业有限公司 | Method for analyzing content of posaconazole enteric-coated tablets |
| 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 |
Non-Patent Citations (2)
| Title |
|---|
| 吴伟;何梅凤;郭泽莉;钟建文;: "HPLC法测定泊沙康唑滴眼液的含量", 中国药房, no. 25, 3 July 2013 (2013-07-03) * |
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