CN115248273B - Method for detecting related substances of salbutamol sulfate solution for inhalation - Google Patents
Method for detecting related substances of salbutamol sulfate solution for inhalation Download PDFInfo
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- CN115248273B CN115248273B CN202210707016.0A CN202210707016A CN115248273B CN 115248273 B CN115248273 B CN 115248273B CN 202210707016 A CN202210707016 A CN 202210707016A CN 115248273 B CN115248273 B CN 115248273B
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- 238000000034 method Methods 0.000 title claims abstract description 40
- 239000000126 substance Substances 0.000 title claims abstract description 35
- BNPSSFBOAGDEEL-UHFFFAOYSA-N albuterol sulfate Chemical compound OS(O)(=O)=O.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 BNPSSFBOAGDEEL-UHFFFAOYSA-N 0.000 title claims abstract description 24
- 239000012535 impurity Substances 0.000 claims abstract description 47
- 238000001514 detection method Methods 0.000 claims abstract description 19
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims abstract description 12
- QWSZRRAAFHGKCH-UHFFFAOYSA-M sodium;hexane-1-sulfonate Chemical compound [Na+].CCCCCCS([O-])(=O)=O QWSZRRAAFHGKCH-UHFFFAOYSA-M 0.000 claims abstract description 10
- 238000004128 high performance liquid chromatography Methods 0.000 claims abstract description 3
- 239000000243 solution Substances 0.000 claims description 33
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims description 12
- 229960002052 salbutamol Drugs 0.000 claims description 12
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- AAEQXEDPVFIFDK-UHFFFAOYSA-N 3-(4-fluorobenzoyl)-2-(2-methylpropanoyl)-n,3-diphenyloxirane-2-carboxamide Chemical compound C=1C=CC=CC=1NC(=O)C1(C(=O)C(C)C)OC1(C=1C=CC=CC=1)C(=O)C1=CC=C(F)C=C1 AAEQXEDPVFIFDK-UHFFFAOYSA-N 0.000 claims description 4
- 229910019142 PO4 Inorganic materials 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 2
- 238000002347 injection Methods 0.000 claims description 2
- 239000007924 injection Substances 0.000 claims description 2
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 claims description 2
- 229910052708 sodium Inorganic materials 0.000 claims description 2
- 239000011734 sodium Substances 0.000 claims description 2
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 abstract description 4
- 230000035945 sensitivity Effects 0.000 abstract description 3
- 230000000052 comparative effect Effects 0.000 description 13
- 230000006978 adaptation Effects 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 6
- 238000000926 separation method Methods 0.000 description 6
- 238000011003 system suitability test Methods 0.000 description 4
- 229940098458 powder spray Drugs 0.000 description 3
- XUKUURHRXDUEBC-SXOMAYOGSA-N (3s,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-SXOMAYOGSA-N 0.000 description 2
- 230000009798 acute exacerbation Effects 0.000 description 2
- 239000000443 aerosol Substances 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- 230000008676 import Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000003908 quality control method Methods 0.000 description 2
- 238000010200 validation analysis Methods 0.000 description 2
- 206010008479 Chest Pain Diseases 0.000 description 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 1
- 206010014561 Emphysema Diseases 0.000 description 1
- 101000777138 Homo sapiens Ubiquitin carboxyl-terminal hydrolase 42 Proteins 0.000 description 1
- 208000019693 Lung disease Diseases 0.000 description 1
- 208000037656 Respiratory Sounds Diseases 0.000 description 1
- 102100031310 Ubiquitin carboxyl-terminal hydrolase 42 Human genes 0.000 description 1
- 206010047924 Wheezing Diseases 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000000048 adrenergic agonist Substances 0.000 description 1
- 229940126157 adrenergic receptor agonist Drugs 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 102000016966 beta-2 Adrenergic Receptors Human genes 0.000 description 1
- 108010014499 beta-2 Adrenergic Receptors Proteins 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000010189 synthetic method Methods 0.000 description 1
Classifications
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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
-
- 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
- G01N30/06—Preparation
-
- 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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
-
- 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
- G01N30/86—Signal analysis
- G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
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Abstract
The application relates to the technical field of detection methods, and particularly discloses a detection method for related substances of salbutamol sulfate solution for inhalation, which adopts a high performance liquid chromatography for detection, wherein the chromatographic conditions are as follows: mobile phase: mobile phase A, mobile phase B; the mobile phase A is sodium hexanesulfonate solution, and the mobile phase B is methanol. The method can effectively detect the related substances in the salbutamol sulfate solution for inhalation, has the advantages of strong specificity, high sensitivity and comprehensive impurity control, and can better control the quality of the preparation.
Description
Technical Field
The application relates to the technical field of detection methods, in particular to a detection method of salbutamol sulfate solution related substances for inhalation.
Background
Salbutamol sulfate is a selective beta 2-adrenergic receptor agonist and is mainly used for treating symptoms such as acute exacerbation of bronchial asthma, acute exacerbation of chronic obstructive pulmonary disease, emphysema, asthmatic bronchitis, acute bronchitis, wheezing caused by pulmonary diseases, chest distress and the like. The prior salbutamol sulfate is clinically and commonly used mainly for inhalation aerosol, inhalation powder spray and inhalation liquid preparation, wherein the inhalation liquid preparation can not only avoid the problems of environmental pollution caused by the propellant in the inhalation aerosol, higher requirements on breathing and starting atomization coordination, but also avoid the defects of strong hygroscopicity, higher requirements on inhalation flow rate and the like of the inhalation powder spray, and compared with other treatment modes, the inhalation powder spray is more convenient to use and takes effect more quickly.
However, in the current pharmacopoeias of many countries, such as EP10.0, USP42, chP2020, there is no record of salbutamol sulphate solution for inhalation; in BP2019, although the salbutamol sulfate solution for inhalation was collected, there were few detectable impurities.
Therefore, the quality control method of salbutamol sulfate solution for inhalation needs to be further developed, improved and perfected.
Disclosure of Invention
In order to better control the quality of salbutamol sulfate solution for inhalation, the application provides a detection method of related substances of salbutamol sulfate solution for inhalation.
The application provides a detection method of salbutamol sulfate solution related substances for inhalation, which adopts the following technical scheme:
the detection method of the salbutamol sulfate solution related substances for inhalation is characterized in that the detection is carried out by adopting a high performance liquid chromatography, and the chromatographic conditions are as follows:
mobile phase: mobile phase A, mobile phase B;
the mobile phase A is sodium hexanesulfonate solution, and the mobile phase B is methanol;
the mobile phase was eluted using the following gradient:
。
by adopting the technical scheme, the mobile phase A of the application selects sodium hexanesulfonate solution, and the mobile phase B selects methanol; by adopting the method, all known impurities are detected in the related substance method, the separation degree among peaks meets the requirement, and the related substances of the sample can be accurately detected.
Preferably, the sodium hexanesulfonate solution is prepared by the following method: taking 2.62-2.72g of 1-hexane sodium sulfonate and 2.45-2.55g of phosphate, adding water to dissolve and dilute to 1000ml, and regulating the pH value to 3.6-3.7 by using phosphoric acid solution.
Preferably, the sodium hexanesulfonate solution is prepared by the following method: 2.67g of sodium 1-hexane sulfonate and 2.5g of phosphate are taken, dissolved in water and diluted to 1000ml, and the pH value is adjusted to 3.65 by using a phosphoric acid solution.
Preferably, the chromatographic conditions further comprise: the column size was 4.6X105 mm, 5. Mu.m.
Preferably, the chromatographic conditions further comprise: the column temperature of the chromatographic column is 20-30 ℃.
Preferably, the column temperature of the chromatographic column is 25 ℃.
Preferably, the chromatographic conditions further comprise: the detection wavelength is 218-222nm.
Preferably, the detection wavelength is 220nm.
Preferably, the chromatographic conditions further comprise: the sample injection amount is 10-20 mu l.
Preferably, the detected related substances include: impurity A, B, C, D, E, F, G, I, J, K, L, M and 5-hydroxy salbutamol;
the correction factor of the impurity A, B, C, E, I, J, M, K, 5-hydroxy salbutamol is 1.0;
the correction factor of the impurity D is 0.4; the correction factor of the impurity F is 1.2; the correction factor of the impurity L is 1.8; the correction factor of the impurity G is 1.4.
In summary, the application has the following beneficial effects:
the method can effectively detect the related substances in the salbutamol sulfate solution for inhalation, and has the advantages of strong specificity and high sensitivity. The quality of the preparation can be better controlled.
Drawings
FIG. 1 is a system adaptation representative map of the method of example 1 of the present application;
FIG. 2 is a typical spectrum of system applicability of the method of example 2 of the present application;
FIG. 3 is a typical pattern of system adaptation of the method of comparative example 1;
FIG. 4 is a typical pattern of system adaptations (impurity I) for the method of comparative example 1;
FIG. 5 is a typical pattern of system adaptation of the method of comparative example 2;
FIG. 6 is a system adaptation representative of the method of comparative example 3;
fig. 7 is a system adaptation representative map of the method of comparative example 4.
Detailed Description
The application is described in further detail below with reference to the drawings and examples.
Examples
There are several synthetic methods for salbutamol sulphate, which produce different impurities in different contractual routes. Among the known impurities of salbutamol sulphate, the method of the application mainly detects 13 known impurities A, B, C, D, E, F, G, I, J, K, L, M and 5-hydroxy salbutamol of salbutamol sulphate.
The structures of impurities A, B, C, D, E, F, G, I, J, K, L, M and 5-hydroxy salbutamol are shown below, respectively:
example 1
A method for detecting salbutamol sulfate solution related substances for inhalation comprises the following steps of (1) and (1).
TABLE 1
Table 2: system suitability test results (example 1)
According to the analysis of fig. 1 and table 2, the method of example 1 was adopted, the separation degree of impurity J from salbutamol peak was 1.66, and the impurities could be separated, but the baseline fluctuation was large, and further optimization of the method was required.
Example 2
A method for detecting salbutamol sulfate solution related substances for inhalation, wherein the chromatographic conditions are shown in Table 3.
TABLE 3 Table 3
Table 4: system suitability test results (example 2)
From the analysis shown in FIG. 2 and Table 4, it was found that each known impurity was detected in the related substance method by the method of example 2, and the degree of separation between the peaks was satisfactory. Therefore, the method has the advantages of good specificity, high sensitivity and comprehensive impurity control, and can provide better quality control for the salbutamol sulfate solution for inhalation.
Comparative example
Comparative example 1
According to the detection method of the related substances of the salbutamol sulfate in Chinese pharmacopoeia, the chromatographic conditions are shown in table 5.
TABLE 5
Table 6: system applicability test results (method of related substances of 2015 edition of Chinese pharmacopoeia)
From the analyses shown in fig. 3 and 4 and table 6, it was found that each known impurity was detected in the related substance method, and that neither impurity a nor impurity B nor impurity K nor impurity M was separated.
Comparative example 2
The chromatographic conditions of the detection method of the related substances of the salbutamol sulfate in EP9.0 are shown in Table 7.
TABLE 7
Table 8: system suitability test results (EP 9.0 related substance method)
From the analysis of fig. 5 and table 8, it was found that each known impurity was detected in the related substance method, and that the albuterol peak was separated from impurity J by only 0.9.
Comparative example 3
The chromatographic conditions of the detection method of the relevant substances of the salbutamol sulfate solution for inhalation according to the import registration standard JX20100320 are shown in Table 9.
TABLE 9
Table 10: system applicability test results (import registration Standard related substance method)
From the analysis of FIG. 6 and Table 10, it was found that each known impurity was detected in the related substance method, that the impurity J was separated from the salbutamol peak by only 0.9, and that neither the impurities L and M nor the impurities D and F were separated.
Comparative example 4
A method for detecting salbutamol sulfate solution related substances for inhalation, wherein the chromatographic conditions are shown in Table 11.
TABLE 11
Table 12: system suitability test results (comparative example 4)
| RT(min) | RRT | Attribution to | Degree of separation | Theoretical plate number | Tailing factor |
| 11.880 | 0.78 | 5-hydroxy salbutamol | \ | 7251 | 0.83 |
| 14.374 | 0.94 | Impurity J | 4.39 | 9924 | 0.89 |
| 15.256 | 1.00 | API | 1.47 | 9860 | 1.05 |
| 21.168 | 1.39 | Impurity B | 9.04 | 14886 | 1.00 |
| 24.627 | 1.61 | Impurity A | 5.12 | 22597 | 1.02 |
| 26.820 | 1.76 | Impurity K | 3.40 | 28535 | 1.02 |
| 31.096 | 2.04 | Impurity M | 7.15 | 49244 | 1.03 |
| 33.001 | 2.16 | Impurity C | 3.44 | 57782 | 1.02 |
| 34.076 | 2.23 | Impurity E | 2.01 | 68782 | 1.03 |
| 38.039 | 2.49 | Impurity D | 6.88 | 57647 | 0.91 |
| 38.858 | 2.55 | Impurity G | 1.46 | 101281 | 1.02 |
| 54.441 | 3.57 | Impurity I | 41.31 | 671395 | 1.08 |
From the analysis of fig. 7 and table 12, it was found that each known impurity was detected in the related substance method, but the impurity J was separated from the albuterol peak by 1.47, and the impurity D was separated from the impurity G by 1.46, which were both less than 1.5.
As can be seen from the data of examples 1-2 and comparative examples 1-4, the method of comparative examples 1-4 can detect impurities in the related substances, but the separation degree of the impurity quality inspection is less than 1.5, so that the separation between the impurities is not satisfactory, although the method has a great influence on the detection of the related substances of salbutamol sulfate solution when changing the mobile phase or chromatographic column.
The methodological validation report of example 2 of the present application is shown in table 13 for validation items and results.
TABLE 13
The present embodiment is only for explanation of the present application and is not to be construed as limiting the present application, and modifications to the present embodiment, which may not creatively contribute to the present application as required by those skilled in the art after reading the present specification, are all protected by patent laws within the scope of claims of the present application.
Claims (6)
1. The detection method of the salbutamol sulfate solution related substances for inhalation is characterized in that the detection is carried out by adopting a high performance liquid chromatography, and the chromatographic conditions are as follows:
mobile phase: mobile phase A, mobile phase B;
the mobile phase A is sodium hexanesulfonate solution, and the mobile phase B is methanol;
the sodium hexanesulfonate solution is prepared by the following method: taking 2.62-2.72g of 1-hexane sodium sulfonate and 2.45-2.55g of phosphate, adding water to dissolve and dilute to 1000ml, and regulating the pH value to 3.6-3.7 by using phosphoric acid solution;
the chromatographic column is Thermo Acclaim 120AC8, the specification is 4.6X105 mm, the detection wavelength is 218-222nm, the column temperature of the chromatographic column is 20-30 ℃, and the flow rate is 1.0mL/min;
the mobile phase was eluted using the following gradient:
The detected related substances comprise: impurity A, B, C, D, E, F, G, I, J, K, L, M and 5-hydroxy salbutamol;
the structures of the impurity A, B, C, D, E, F, G, I, J, K, L, M and 5-hydroxy salbutamol are shown below respectively:
。
2. the method for detecting substances related to salbutamol sulfate solution for inhalation according to claim 1, wherein the sodium hexanesulfonate solution is prepared by the following method: 2.67g of sodium 1-hexane sulfonate and 2.5g of phosphate are taken, dissolved in water and diluted to 1000ml, and the pH value is adjusted to 3.65 by using a phosphoric acid solution.
3. The method for detecting a substance related to salbutamol sulphate solution for inhalation according to claim 1, wherein the column temperature of the chromatographic column is 25 ℃.
4. The method for detecting a substance related to salbutamol sulphate solution for inhalation according to claim 1, wherein the detection wavelength is 220nm.
5. A method for detecting a substance related to salbutamol sulphate solution for inhalation according to claim 1, wherein the chromatographic conditions further comprise: the sample injection amount is 10-20 mu l.
6. A method for detecting a salbutamol sulphate solution related substance for inhalation according to claim 1, wherein the correction factor of the impurity A, B, C, E, I, J, M, K, 5-hydroxy salbutamol is 1.0;
the correction factor of the impurity D is 0.4; the correction factor of the impurity F is 1.2; the correction factor of the impurity L is 1.8; the correction factor of the impurity G is 1.4.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108181463A (en) * | 2017-12-11 | 2018-06-19 | 华南农业大学 | A kind of beta-2-agonists haptens and artificial antibody and its preparation method and application |
| CN108627597A (en) * | 2018-05-25 | 2018-10-09 | 成都倍特药业有限公司 | A kind of detection method of the salbutamol sulfate in relation to substance |
| CN110632205A (en) * | 2019-10-08 | 2019-12-31 | 四川普锐特医药科技有限责任公司 | Method for detecting salbutamol sulfate solution related substances for inhalation |
| CN114034782A (en) * | 2021-09-23 | 2022-02-11 | 北京四环科宝制药有限公司 | Method for detecting salbutamol sulfate related substances |
-
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108181463A (en) * | 2017-12-11 | 2018-06-19 | 华南农业大学 | A kind of beta-2-agonists haptens and artificial antibody and its preparation method and application |
| CN108627597A (en) * | 2018-05-25 | 2018-10-09 | 成都倍特药业有限公司 | A kind of detection method of the salbutamol sulfate in relation to substance |
| CN110632205A (en) * | 2019-10-08 | 2019-12-31 | 四川普锐特医药科技有限责任公司 | Method for detecting salbutamol sulfate solution related substances for inhalation |
| CN114034782A (en) * | 2021-09-23 | 2022-02-11 | 北京四环科宝制药有限公司 | Method for detecting salbutamol sulfate related substances |
Non-Patent Citations (4)
| Title |
|---|
| Four Hapten Spacer Sites Modulating Class Specificity: Nondirectional Multianalyte Immunoassay for 31 β-Agonists and Analogues;Lanteng Wang 等;Analytical Chemistry;第90卷(第4期);2716-2724 * |
| 沙丁胺醇联合异丙托澳按吸人治 疗慢性阻塞性肺疾病疗效观察;孟超;黑龙江医药;第27卷(第2期);361-363 * |
| 高效液相色谱法测定硫酸沙丁胺醇有关物质的含量;王鑫 等;安徽医药;第24卷(第2期);242-246 * |
| 黄嘌呤氧化还原酶抑制剂的代谢机制及毒性预测研究;周丽屏;中国博士学位论文全文数据库医药卫生科技辑(第1期);全文 * |
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