CN117825569A - Method for measuring dibenzylamine content in norepinephrine bitartrate injection - Google Patents
Method for measuring dibenzylamine content in norepinephrine bitartrate injection Download PDFInfo
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- CN117825569A CN117825569A CN202410041337.0A CN202410041337A CN117825569A CN 117825569 A CN117825569 A CN 117825569A CN 202410041337 A CN202410041337 A CN 202410041337A CN 117825569 A CN117825569 A CN 117825569A
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- BWLUMTFWVZZZND-UHFFFAOYSA-N Dibenzylamine Chemical compound C=1C=CC=CC=1CNCC1=CC=CC=C1 BWLUMTFWVZZZND-UHFFFAOYSA-N 0.000 title claims abstract description 64
- 238000002347 injection Methods 0.000 title claims abstract description 39
- 239000007924 injection Substances 0.000 title claims abstract description 39
- LNBCGLZYLJMGKP-LUDZCAPTSA-N 4-[(1r)-2-amino-1-hydroxyethyl]benzene-1,2-diol;(2r,3r)-2,3-dihydroxybutanedioic acid;hydrate Chemical compound O.OC(=O)[C@H](O)[C@@H](O)C(O)=O.NC[C@H](O)C1=CC=C(O)C(O)=C1 LNBCGLZYLJMGKP-LUDZCAPTSA-N 0.000 title claims abstract description 36
- 229960001695 norepinephrine bitartrate Drugs 0.000 title claims abstract description 36
- 238000000034 method Methods 0.000 title claims abstract description 21
- 239000000243 solution Substances 0.000 claims abstract description 37
- 238000001514 detection method Methods 0.000 claims abstract description 26
- 239000013558 reference substance Substances 0.000 claims abstract description 15
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims abstract description 14
- 238000010828 elution Methods 0.000 claims abstract description 9
- 239000007788 liquid Substances 0.000 claims abstract description 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000012071 phase Substances 0.000 claims abstract description 8
- 239000012488 sample solution Substances 0.000 claims abstract description 8
- 238000012360 testing method Methods 0.000 claims abstract description 8
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims abstract description 6
- 239000000945 filler Substances 0.000 claims abstract description 6
- 239000007791 liquid phase Substances 0.000 claims abstract description 6
- 239000000126 substance Substances 0.000 claims abstract description 6
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims abstract description 4
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 4
- PBCJIPOGFJYBJE-UHFFFAOYSA-N acetonitrile;hydrate Chemical compound O.CC#N PBCJIPOGFJYBJE-UHFFFAOYSA-N 0.000 claims abstract description 3
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- 239000000523 sample Substances 0.000 claims description 12
- 238000012417 linear regression Methods 0.000 claims description 4
- 239000012153 distilled water Substances 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 239000012088 reference solution Substances 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 4
- 239000003814 drug Substances 0.000 abstract description 4
- 230000002349 favourable effect Effects 0.000 abstract description 2
- 239000000047 product Substances 0.000 description 5
- 208000001953 Hypotension Diseases 0.000 description 4
- 230000036543 hypotension Effects 0.000 description 4
- 238000000926 separation method Methods 0.000 description 4
- 239000012535 impurity Substances 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000002904 solvent Substances 0.000 description 3
- 239000011550 stock solution Substances 0.000 description 3
- 239000012085 test solution Substances 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000004807 localization Effects 0.000 description 2
- 239000011259 mixed solution Substances 0.000 description 2
- 230000001502 supplementing effect Effects 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-M 3-carboxy-2,3-dihydroxypropanoate Chemical compound OC(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-M 0.000 description 1
- 208000010496 Heart Arrest Diseases 0.000 description 1
- 206010021137 Hypovolaemia Diseases 0.000 description 1
- 206010000891 acute myocardial infarction Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 238000003113 dilution method Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 208000028591 pheochromocytoma Diseases 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 230000035939 shock Effects 0.000 description 1
- REFMEZARFCPESH-UHFFFAOYSA-M sodium;heptane-1-sulfonate Chemical compound [Na+].CCCCCCCS([O-])(=O)=O REFMEZARFCPESH-UHFFFAOYSA-M 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a method for determining the content of dibenzylamine in norepinephrine bitartrate injection, belonging to the technical field of medical analysis. The invention comprises the steps of 1) preparing a reference substance solution and a test substance solution; 2) Setting high performance liquid phase detection conditions: a chromatographic column using octadecylsilane chemically bonded silica as a filler is adopted; the mobile phase is 2 per mill phosphoric acid water-acetonitrile, and gradient elution is carried out; 3) Precisely sucking the reference substance solution and the sample solution respectively, injecting into a liquid chromatograph, and starting to detect and record chromatograms; 4) And drawing a standard curve to obtain a standard curve equation, and calculating the dibenzylamine content in the norepinephrine bitartrate injection to be detected. The invention can rapidly, effectively, accurately and reliably separate and detect dibenzylamine in the norepinephrine bitartrate injection, is favorable for improving the product quality of the norepinephrine bitartrate injection and improves the medication safety of patients.
Description
Technical Field
The invention belongs to the technical field of medical analysis, and particularly relates to a method for measuring the content of dibenzylamine in norepinephrine bitartrate injection.
Background
Norepinephrine bitartrate injection for treating hypotension caused by acute myocardial infarction, extracorporeal circulation, etc.; for shock, hypotension or hypotension after pheochromocytoma excision caused by hypovolemia, the product is used as an auxiliary treatment for supplementing blood volume in emergency, so that the blood pressure rises, and cerebral and coronary perfusion is temporarily maintained until the treatment for supplementing blood volume takes place; can also be used for maintaining hypotension during intraspinal block and after resuscitation due to cardiac arrest.
The method under the item of the related substances of the norepinephrine bitartrate in European pharmacopoeia 10.0 adopts sodium heptanesulfonate solution-acetonitrile gradient elution, the retention time of the norepinephrine peak is about 3 minutes, the relative retention time of dibenzylamine peak is about 6.9 respectively, the flow rate is as high as 4mL/min, the mobile phase needs nitrogen protection, and the detection difficulty is high. Therefore, an improvement on the detection method of dibenzylamine in the norepinephrine bitartrate injection is needed, and a rapid and effective detection method is established, so that the product quality of the norepinephrine bitartrate injection is improved, and the medication safety of patients is improved.
Disclosure of Invention
Aiming at the problems in the prior art, the technical problem to be solved by the invention is to provide a method for measuring the content of dibenzylamine in the norepinephrine bitartrate injection, which can quickly and effectively separate and detect dibenzylamine in the norepinephrine bitartrate injection, improve the product quality of the norepinephrine bitartrate injection and improve the medication safety of patients.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
a method for determining the content of dibenzylamine in norepinephrine bitartrate injection, comprising the following steps:
1) Preparing a reference substance solution and a test substance solution;
2) Setting high performance liquid phase detection conditions: adopting a chromatographic column taking octadecylsilane chemically bonded silica as a filler, wherein the column temperature of the chromatographic column is 28-32 ℃; the mobile phase is 2 per mill phosphoric acid water-acetonitrile, and gradient elution is carried out;
3) Precisely sucking the reference substance solution and the sample solution respectively, injecting into a liquid chromatograph, and starting to detect and record chromatograms;
4) And drawing a standard curve to obtain a standard curve equation, and calculating the dibenzylamine content in the norepinephrine bitartrate injection to be detected.
Preferably, in the step 1), the preparation method of the reference substance solution comprises the following steps: the dibenzylamine reference substance is weighed, distilled water is added to dilute the dibenzylamine reference substance into a solution with 2 mug of dibenzylamine per mL, and the solution is used as a reference substance solution.
Preferably, in the step 2), the column is Agilent XDB-C8, the specification is 250mm×4.6mm, the filler particle diameter is 5 μm, and the column temperature is 30deg.C.
Preferably, in the step 2), the volume ratio of 2%o phosphoric acid water to acetonitrile in the mobile phase is 82:18.
Preferably, in the step 2), the gradient elution flow rate is 0.95 to 1.05mL/min.
Preferably, in the step 2), the gradient elution flow rate is 1mL/min.
Preferably, in the step 3), the sample injection amounts of the sample solution and the control solution are 20 μl.
Preferably, in the step 3), the detection wavelength of the liquid chromatograph is 230nm.
Preferably, in the step 4), a linear regression equation is performed according to the chromatogram with the peak area a as the ordinate and the concentration C as the abscissa, and the linear equation of dibenzylamine is a= 0.6276C-0.0007.
Preferably, the linear concentration of dibenzylamine ranges from 0.0517. Mu.g/mL to 4.1359. Mu.g/mL, the quantitative limit is 0.01067. Mu.g/mL, and the detection limit is 0.005337. Mu.g/mL.
Compared with the prior art, the invention has the beneficial effects that:
1) The auxiliary materials and degradation products generated by the test sample under various damage conditions do not interfere with the determination of dibenzylamine, the detection specificity of related substances is good, and meanwhile, the separation and the detection result of dibenzylamine are not influenced when chromatographic condition parameters are slightly changed, so that the durability is good;
2) Compared with the method for measuring related substances under the norepinephrine bitartrate item of European pharmacopoeia version 10.0, the method adopts a high-efficiency liquid phase method to measure the content of dibenzylamine in the norepinephrine bitartrate injection, so that the main component and the dibenzylamine can be well separated, and other impurities, auxiliary material peaks and solvent peaks do not interfere with detection;
3) The invention can rapidly, effectively, accurately and reliably separate and detect dibenzylamine in the norepinephrine bitartrate injection, is favorable for improving the product quality of the norepinephrine bitartrate injection and improves the medication safety of patients.
Drawings
FIG. 1 is a test chromatogram under chromatographic conditions of example 1;
FIG. 2 is a dibenzylamine standard graph.
Detailed Description
The present invention will be further described with reference to specific embodiments for the purpose of making the objects, technical solutions and advantages of the present invention more apparent. Unless otherwise indicated, all technical means used in the following examples are conventional means well known to those skilled in the art.
In the following examples, the following instrument and reagent models were used:
the model of the high performance liquid chromatograph is Thermo U3000;
phosphoric acid and dibenzylamine are all analytically pure commercial products; acetonitrile is a commercial product of chromatographic grade.
The conditions for high performance liquid phase detection used in the following examples were as follows:
chromatographic column: agilent XDB-C8 (250 x 4.6mm 5 μm)
Flow rate: 1mL/min;
column temperature: 30 ℃;
mobile phase: 2 per mill of phosphoric acid water and acetonitrile in a volume ratio of 82:18;
detection wavelength: 230nm.
Example 1
(1) Preparing a control solution and a test solution: the sample solution is an injection sample, and is directly injected; the dibenzylamine reference substance is weighed and added with water for dissolution, and the concentration of the dibenzylamine reference substance solution is 2 mug/mL.
(2) Setting high performance liquid phase detection conditions: the chromatographic column is Agilent XDB-C8 (250 x 4.6mm 5 μm), octadecylsilane chemically bonded silica is used as filler, the volume ratio of 2%phosphoric acid water to acetonitrile in the mobile phase is 82:18, gradient elution is carried out at the flow rate of 1mL/min, and the column temperature is 30 ℃; the detection wavelength is 230nm;
(3) 20 mu L of the sample solution and the reference solution are respectively sucked precisely, injected into a liquid chromatograph, and the chromatogram is recorded, and the result is shown in figure 1.
FIG. 1 shows a test chromatogram under the chromatographic condition of the present example, and as can be seen from FIG. 1, dibenzylamine and main component can be well separated under the detection wavelength of 230nm under the chromatographic condition, and the solvent peak and the blank auxiliary material peak do not interfere with the measurement, thereby conforming to the standard.
According to the chromatogram of fig. 1, a linear regression equation is made with peak area a on the ordinate and concentration C on the abscissa, and the linear equation for dibenzylamine is a= 0.6276C-0.0007. The linear concentration range of dibenzylamine is 0.0517-4.1359 mug/mL, the quantitative limit is 0.01067 mug/mL, and the detection limit is 0.005337 mug/mL.
Example 2
The detection method of example 1 was subjected to method verification, and verification was performed in terms of system applicability, quantitative limit, detection limit, linear relationship, precision, solution stability, and the like, respectively.
1. System suitability determination
Dissolving norepinephrine bitartrate in water to obtain a positioning solution containing 10 μg of norepinephrine bitartrate per 1 mL.
Dibenzylamine is taken and dissolved and diluted by adding water to prepare a positioning solution containing 2 mug of dibenzylamine in each 1 mL.
The mixed solution containing 2mg of norepinephrine bitartrate and 2 mug of dibenzylamine bitartrate in each 1mL is prepared by diluting the norepinephrine bitartrate and dibenzylamine with water, and the mixed solution is used as a system applicability solution.
The results are shown in Table 1 below.
TABLE 1 impurity localization and separation degree
| Name of the name | Blank space | Norepinephrine bitartrate | Dibenzylamine |
| Single solution retention time (minutes) | —— | 0.918 | 3.605 |
| System applicability solution (minutes) | —— | 0.921 | 3.605 |
| Degree of separation | —— | —— | 25.5 |
As is clear from the localization and separation degree of the impurities in Table 1, the main component and dibenzylamine can be separated effectively without interfering with the detection.
2. Quantitative limit and detection limit experiments
Dibenzylamine was diluted with water to prepare a stock solution containing 2 μg dibenzylamine per 1 mL.
The quantitative limit (S/N is more than or equal to 10) and the detection limit (S/N is more than or equal to 3) of the sample are measured by a progressive dilution method.
The results are shown in Table 2 below.
TABLE 2 detection limits and quantification limits
As is clear from the detection limit and the quantitative limit of Table 2, dibenzylamine at a low concentration can be efficiently detected under the chromatographic conditions.
3. Precision of sample injection
The dibenzylamine is diluted by water to prepare 2 mug of dibenzylamine in each 1mL, and the mixture is used as a sample injection precision solution.
Under the above chromatographic conditions, 20. Mu.L of the mixture was injected into a liquid chromatograph, and the sample was continuously introduced 6 times, and the peak area was recorded.
The results are shown in Table 3 below.
TABLE 3 sample injection precision results
| Number of sample injection needles | Dibenzylamine peak area |
| 1 | 1.29144 |
| 2 | 1.29899 |
| 3 | 1.29825 |
| 4 | 1.29901 |
| 5 | 1.29961 |
| 6 | 1.29797 |
| RSD％ | 0.23 |
As can be seen from the sample injection precision results in Table 3, the sample injection precision under the chromatographic conditions was good by continuously injecting 6 needles.
4. Solution stability
Dibenzylamine was diluted with water to prepare a control solution containing 2 μg of dibenzylamine per 1 mL.
The injection is taken and directly injected to be used as a test solution (2 mg/mL).
Under the above chromatographic conditions, samples were taken at different times, respectively, and their daily stabilities were examined.
The results are shown in tables 4 and 5 below.
TABLE 4 stability results of control solutions
| Time (hours) | Dibenzylamine peak area |
| 0 | 1.29144 |
| 1 | 1.29797 |
| 4 | 1.30377 |
| 6 | 1.30499 |
| 7 | 1.30233 |
| 10 | 1.30739 |
| 14 | 1.30971 |
| 22 | 1.31566 |
| 30 | 1.32576 |
| RSD％ | 0.76 |
TABLE 5 test solution stability results
As is clear from tables 4 and 5, the test sample solutions were stable within 48 hours, and the control solutions were stable within 30 hours.
5. Linearity and range
Dibenzylamine was taken, dissolved in water and diluted to give a stock solution of 4 μg per 1mL as a linear stock solution. The above solutions were diluted with solvents in the following Table 6 to prepare linear solutions of respective concentrations.
Table 6 linear solution formulation table
Under the above chromatographic conditions, preparing linear solutions according to the limits of 2.5%,10%,50%,100% and 200%, precisely measuring 20 mu L of each solution, respectively injecting into a high performance liquid chromatograph, recording a chromatogram, measuring the peak area, and performing linear regression by taking the peak area A as an ordinate and the concentration C as an abscissa. The results are shown in Table 7 below.
TABLE 7 dibenzylamine linearity test results
As can be seen from Table 7 and FIG. 2, under the present chromatographic conditions, the dibenzylamine linearity results were good. Dibenzylamine has good linearity between the concentration and the peak area in the range of 0.0517 mug/mL-4.1359 mug/mL, and the linear equation is: a= 0.6276C-0.0007, and the correlation coefficient r=1.0000.
The foregoing examples are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the examples, and the examples and features in the examples in the present application may be arbitrarily combined with each other without collision. Any other changes, modifications, substitutions, combinations, and simplifications that do not depart from the spirit and principles of the invention are intended to be equivalent substitutes for those that do not depart from the spirit and principles of the invention. In addition, technical details not described in detail in the present specification belong to the known technology of those skilled in the art, so the present specification is not repeated.
Claims (10)
1. A method for determining the content of dibenzylamine in norepinephrine bitartrate injection, which is characterized by comprising the following steps:
1) Preparing a reference substance solution and a test substance solution;
2) Setting high performance liquid phase detection conditions: adopting a chromatographic column taking octadecylsilane chemically bonded silica as a filler, wherein the column temperature of the chromatographic column is 28-32 ℃; the mobile phase is 2 per mill phosphoric acid water-acetonitrile, and gradient elution is carried out;
3) Precisely sucking the reference substance solution and the sample solution respectively, injecting into a liquid chromatograph, and starting to detect and record chromatograms;
4) And drawing a standard curve to obtain a standard curve equation, and calculating the dibenzylamine content in the norepinephrine bitartrate injection to be detected.
2. The method for determining the content of dibenzylamine in norepinephrine bitartrate injection according to claim 1, wherein in the step 1), the preparation method of the reference solution is as follows: the dibenzylamine reference substance is weighed, distilled water is added to dilute the dibenzylamine reference substance into a solution with 2 mug of dibenzylamine per mL, and the solution is used as a reference substance solution.
3. The method for determining the content of dibenzyl amine in norepinephrine bitartrate injection according to claim 1, wherein in the step 2), the chromatographic column is Agilent XDB-C8 with the specification of 250mm×4.6mm, the filler particle size is 5 μm, and the column temperature of the chromatographic column is 30 ℃.
4. The method for determining the content of dibenzylamine in a norepinephrine bitartrate injection according to claim 1, wherein in the step 2), the volume ratio of 2%o phosphoric acid water to acetonitrile in the mobile phase is 82:18.
5. The method for determining the dibenzyl amine content of norepinephrine bitartrate injection according to claim 1, wherein in the step 2), the gradient elution flow rate is 0.95-1.05 mL/min.
6. The method for determining the dibenzylamine level of a norepinephrine bitartrate injection of claim 5, wherein in step 2), the gradient elution flow rate is 1mL/min.
7. The method for determining the content of dibenzylamine in a norepinephrine bitartrate injection according to claim 1, wherein in the step 3), the sample injection amounts of the sample solution and the control solution are 20 μl.
8. The method for determining the dibenzylamine level of a norepinephrine bitartrate injection according to claim 1, wherein in the step 3), the detection wavelength of the liquid chromatograph is 230nm.
9. The method for determining the content of dibenzylamine in norepinephrine bitartrate injection according to claim 1, wherein in the step 4), a linear regression equation is performed by taking a peak area a as an ordinate and a concentration C as an abscissa according to a chromatogram, and the linear equation of dibenzylamine is a= 0.6276C to 0.0007.
10. The method for determining the content of dibenzylamine in norepinephrine bitartrate injection according to claim 1, wherein the linear concentration of dibenzylamine ranges from 0.0517 μg/mL to 4.1359 μg/mL, the quantitative limit is 0.01067 μg/mL, and the detection limit is 0.005337 μg/mL.
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