CN116879464A - Fluorine [ 18 F]Detection method and application of betazine injection - Google Patents
Fluorine [ 18 F]Detection method and application of betazine injection Download PDFInfo
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- CN116879464A CN116879464A CN202311156348.5A CN202311156348A CN116879464A CN 116879464 A CN116879464 A CN 116879464A CN 202311156348 A CN202311156348 A CN 202311156348A CN 116879464 A CN116879464 A CN 116879464A
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- 229910052731 fluorine Inorganic materials 0.000 title claims abstract description 43
- 239000011737 fluorine Substances 0.000 title claims abstract description 43
- ZWUCUYUBBSFKJG-UHFFFAOYSA-N 3-amino-3-(4-hydroxy-3,5-diiodophenyl)propanoic acid Chemical compound OC(=O)CC(N)C1=CC(I)=C(O)C(I)=C1 ZWUCUYUBBSFKJG-UHFFFAOYSA-N 0.000 title claims abstract description 39
- 238000002347 injection Methods 0.000 title claims abstract description 38
- 239000007924 injection Substances 0.000 title claims abstract description 38
- 238000001514 detection method Methods 0.000 title claims abstract description 34
- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 title abstract 6
- 238000000926 separation method Methods 0.000 claims abstract description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 6
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims abstract description 3
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 3
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 claims description 36
- 230000002285 radioactive effect Effects 0.000 claims description 29
- 239000000243 solution Substances 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 16
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical group CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 15
- 238000010828 elution Methods 0.000 claims description 11
- 239000000126 substance Substances 0.000 claims description 11
- 238000007689 inspection Methods 0.000 claims description 4
- USFZMSVCRYTOJT-UHFFFAOYSA-N Ammonium acetate Chemical compound N.CC(O)=O USFZMSVCRYTOJT-UHFFFAOYSA-N 0.000 claims description 3
- 239000005695 Ammonium acetate Substances 0.000 claims description 3
- 229940043376 ammonium acetate Drugs 0.000 claims description 3
- 235000019257 ammonium acetate Nutrition 0.000 claims description 3
- 238000010812 external standard method Methods 0.000 claims description 3
- 125000001153 fluoro group Chemical group F* 0.000 claims description 3
- 238000004587 chromatography analysis Methods 0.000 claims description 2
- 238000012856 packing Methods 0.000 claims description 2
- 239000012535 impurity Substances 0.000 abstract description 33
- 238000005516 engineering process Methods 0.000 abstract description 5
- 238000004458 analytical method Methods 0.000 abstract description 4
- 238000011161 development Methods 0.000 abstract description 4
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 239000003814 drug Substances 0.000 abstract description 3
- 238000012544 monitoring process Methods 0.000 abstract description 2
- 239000000945 filler Substances 0.000 abstract 1
- 239000000523 sample Substances 0.000 description 45
- 230000014759 maintenance of location Effects 0.000 description 13
- 239000013558 reference substance Substances 0.000 description 9
- 238000005286 illumination Methods 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 6
- RVRCFVVLDHTFFA-UHFFFAOYSA-N heptasodium;tungsten;nonatriacontahydrate Chemical compound O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[W].[W].[W].[W].[W].[W].[W].[W].[W].[W].[W] RVRCFVVLDHTFFA-UHFFFAOYSA-N 0.000 description 6
- 238000011835 investigation Methods 0.000 description 4
- 238000010606 normalization Methods 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 230000004044 response Effects 0.000 description 3
- 239000012488 sample solution Substances 0.000 description 3
- 208000024827 Alzheimer disease Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000012937 correction Methods 0.000 description 2
- YCKRFDGAMUMZLT-BJUDXGSMSA-N fluorine-18 atom Chemical compound [18F] YCKRFDGAMUMZLT-BJUDXGSMSA-N 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 102000013455 Amyloid beta-Peptides Human genes 0.000 description 1
- 108010090849 Amyloid beta-Peptides Proteins 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 229940039227 diagnostic agent Drugs 0.000 description 1
- 239000000032 diagnostic agent Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012216 imaging agent Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000002600 positron emission tomography Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 102000013498 tau Proteins Human genes 0.000 description 1
- 108010026424 tau Proteins Proteins 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- RXPRRQLKFXBCSJ-GIVPXCGWSA-N vincamine Chemical compound C1=CC=C2C(CCN3CCC4)=C5[C@@H]3[C@]4(CC)C[C@](O)(C(=O)OC)N5C2=C1 RXPRRQLKFXBCSJ-GIVPXCGWSA-N 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- 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
- G01N30/26—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
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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)
- Pathology (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Measurement Of Radiation (AREA)
Abstract
The invention relates to the technical field of medicine analysis and detection, in particular to fluorine [ 18 F]A detection method and application of a betazine injection. The detection method comprises separating fluorine by combining a chromatographic column with octadecylsilane chemically bonded silica filler with a specific mobile phase and eluting 18 F]Betazine injection. Fluorine can be obtained by the chromatographic conditions of the present invention 18 F]Fluorine in beta-oxazine injection 18 F]The betazidine and the impurities are well separated, and the impurities have better separation degree, thereby being beneficial to effectively monitoring fluorine [ 18 F]The product quality of the betazine injection guides the development of the product technology.
Description
Technical Field
The invention relates to the technical field of medicine analysis and detection, in particular to fluorine [ 18 F]A detection method and application of a betazine injection.
Background
Fluorine [ 18 F]Betazine 18 Florbetazine) injection is a novel radiodiagnostic drug consisting of fluorine 18 F]Labeled Positron Emission Tomography (PET) imaging agents, targeting beta amyloid (aβ) plaques of the brain, are useful in diagnostic agents for Alzheimer's Disease (AD). The active ingredients are based on the compounds described in the patent 'bishydrazone compounds with high affinity with Abeta protein and Tau protein, derivatives and application (CN201910007703. X)', and are developed through further process and prescription development.
Fluorine [ 18 F]Betazine 18 Florbetazine) injection active ingredients have the following chemical structures:
。
with fluorine [ 18 F]The rapidly growing application of betazine injecta in the market requires for better control of fluorine [ 18 F]The product quality of the beta-oxazine injection, guiding the development of the product technology, is very necessary for fluorine [ 18 F]Fluoro [ in beta-oxazine injection 18 F]And detecting the chemical content, radiochemical purity, impurities and other items of the betazine.
However, to date, there has been no focus on fluorine [ 18 F]Related prior art methods for detecting betazine injection.
Disclosure of Invention
In view of this, the present invention has been made.
First, the present invention provides a fluorine [ 18 F]The detection method of the betazine injection comprises the following steps:
separation of fluorine by chromatography column using octadecylsilane chemically bonded silica packing 18 F]Betazine injection;
wherein the mobile phase A is 8-12 mM ammonium acetate solution; mobile phase B is acetonitrile;
the gradient elution procedure was as follows:
the sum of the volume percentages of the mobile phase A and the mobile phase B in each stage is 100 percent;
the volume percentage of mobile phase A at each stage is as follows:
。
the invention discovers fluorine under the chromatographic conditions by optimizing the chromatographic conditions 18 F]Fluorine in beta-oxazine injection 18 F]The separation degree of the betazine and the impurities is high (the separation degree is more than 1.5), the impurities have better separation degree, the peak type is good, the column effect is good, and the fluorine can be effectively monitored 18 F]The product quality of the betazine injection.
Preferably, the column temperature of the chromatographic column is 25-35 ℃; and/or the flow rate of the mobile phase is 0.5-1.5 mL/min.
More preferably, the column temperature of the chromatographic column is 28-32 ℃; and/or the flow rate of the mobile phase is 0.8-1.2 mL/min.
Preferably, the gradient eluted sample is detected using a ultraviolet detector (VWD).
Preferably, the gradient eluted sample is detected using a Diode Array Detector (DAD).
Preferably, the sample after gradient elution is detected using a radioactive flow detector.
Preferably, an ultraviolet detector and a radioactive flow detector are adopted to detect the sample after gradient elution;
or detecting the sample after gradient elution by using a diode array detector and a radioactive flow detector.
The sample separated by the chromatographic condition can realize the accurate detection of fluorine simultaneously when the ultraviolet detector (or diode array detector) and the radioactive flow detector are combined for detection 18 F]The radiochemical purity and content of the beta-oxazine injection can be accurately analyzed 18 F]The injection of the betazine is introduced by the process and contains radioactive chemical impurities and non-radioactive chemical impurities generated by radiation self-decomposition.
Preferably, the detection method further comprises: fluorine para-using external standard method 18 F]Fluoro [ in beta-oxazine injection 18 F]The chemical content of the betazine is determined.
Preferably, the detection method further comprises: fluorine is normalized by peak area 18 F]And detecting the radiochemical purity of the betazine injection.
Preferably, the detection wavelength of the ultraviolet detector or the diode array detector is 360-370 nm; more preferably 365 to 370nm.
Preferably, the impurity is further detected and analyzed by a diode array detector.
The impurities in the present invention include chemical impurities and radiochemical impurities.
Those skilled in the art can further combine the above preferred embodiments to arrive at other preferred embodiments.
Further, the present invention provides the method for detecting fluorine in any one of the above-mentioned aspects 18 F]Application of the betazine injection in quality inspection of products.
Compared with the prior art, the invention has the beneficial effects that:
the present invention provides fluorine [ 18 F]Method for detecting betazine injection, fluorine [ can be obtained by the chromatographic conditions of the invention 18 F]Fluorine in beta-oxazine injection 18 F]The betazidine and the impurities are well separated, and the impurities have better separation degree, thereby being beneficial to effectively monitoring fluorine [ 18 F]The product quality of the betazine injection guides the development of the product technology.
Drawings
FIG. 1 is an ultraviolet signal chromatogram of the control of example 1.
FIG. 2 is an ultraviolet signal chromatogram of the test sample of example 1.
FIG. 3 is a radioactive signal chromatogram of the test sample of example 1.
FIG. 4 is an ultraviolet signal chromatogram of the control of example 2.
FIG. 5 is an ultraviolet signal chromatogram of the test sample of example 2.
FIG. 6 is a radioactive signal chromatogram of the test sample of example 2.
FIG. 7 is an ultraviolet signal chromatogram of a comparative control.
FIG. 8 is an ultraviolet signal chromatogram of a comparative sample.
FIG. 9 is a radioactive signal chromatogram of a comparative sample.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The examples are not intended to identify the particular technology or conditions, and are either conventional or are carried out according to the technology or conditions described in the literature in this field or are carried out according to the product specifications. The reagents and instruments used, etc. are not identified to the manufacturer and are conventional products available for purchase by regular vendors. Fluorine [ 18 F]The betazine injection is provided by atomic Gaokou Co.
Example 1
This example provides a fluorine [ 18 F]The detection method of the betazine injection comprises the following steps:
preparing a reference substance solution: precision weighing control (fluorine [ the) 19 F]Betazine) 10mg, acetonitrile was added for dissolution and stepwise dilution to a volume of 2. Mu.g/mL.
Preparing a test solution: fluorine [ 18 F]Betazine injection.
Mobile phase A is prepared: ammonium acetate 770.82mg was precisely weighed, dissolved in 1000mL of water, and degassed by ultrasound.
Mobile phase B preparation: 1000mL of acetonitrile was measured and the gas was removed by ultrasonic.
The detection method comprises the following steps: taking a reference substance solution and a sample solution, respectively carrying out sample injection by a high performance liquid chromatograph, wherein the sample injection amounts are 10, and separating by a chromatographic column under the following chromatographic conditions: waters Xbridge C18 reverse phase chromatographic column with column temperature of 30deg.C; gradient elution was performed according to the procedure in table 1; the flow rate of the mobile phase is 1.0 mL/min;
TABLE 1
The separated sample sequentially passes through a diode array detector (detection wavelength is 368 nm) and a radioactive flow detector, and meanwhile, the information of the chemical content, the radiochemical purity and the like of the sample is obtained.
Based on fluorine [ 18 F]Non-radioactive chemical reference of betazine (fluoro [ s ] 19 F]Betazine), obtaining the chemical content of the sample by an external standard method; obtaining fluorine based on peak area normalization method 18 F]Radiochemical purity of the betazine injection.
The detection results are as follows.
The ultraviolet signal chromatogram of the control is shown in fig. 1, and the result shows that the retention time of the control (peak 1) is 15.90 minutes, and the peak area is 2.250mau×min. The control is non-radioactive and therefore has no response to radioactive signals.
The ultraviolet signal chromatogram of the sample is shown in fig. 2, and the result shows that the impurity peak is far away from the main peak (peak 3, 16.018 minutes), the separation degree of the main peak and the impurity peak and each impurity peak is more than 1.5, and the content of the sample can be further calculated according to the concentration of the reference substance, the peak area and the main peak area of the sample.
As shown in FIG. 3, the radioactive signal chromatogram of the sample has a main peak (peak 7) retention time of 16.150 min, and fluorine is obtained by peak area normalization 18 F]The radiochemical purity of the betazine is 92.28%, and each impurity peak in the sample has better separation degree, so that the impurities can be further researched.
Further, the present embodiment examines the system applicability of the above detection method.
(1) System suitability investigation for radiochemical purity detection
Investigation of the target: sequentially taking blank solvent (acetonitrile), matrix solution (without active component fluorine 18 F]The sample injection of the betazine), the reference substance solution and the sample illumination solution is respectively carried out by 1 needle, and the sample injection of the sample solution is carried out by 6 needles continuously.
Inspection standard: in the radioactive chromatogram, the theoretical plate number n of the main radioactive peak is more than or equal to 1000; after decay correction, the retention time and the peak area RSD of the main peak of the 6-needle sample are less than or equal to 5.0%; the tailing factor T is less than or equal to 2; the separation degree of the radioactive main peak and the radioactive impurity peak of the sample illumination solution is more than 1.5. In the ultraviolet chromatogram, the theoretical plate number n of the main peak is more than or equal to 2000;6 needles of the sample to be tested, the retention time of the main peak and the peak area RSD are less than or equal to 5.0 percent; the tailing factor T is less than or equal to 2; the separation degree of the main peak and the adjacent impurity peak of the sample illumination solution is more than 1.5.
The experimental results are shown in Table 2, and the results show that in the radioactive chromatogram, the theoretical plate number n of the radioactive main peak is more than or equal to 1000; after decay correction, the retention time RSD of the main peak of the 6-needle sample is 0.04%, the peak area RSD is 3.8%, and the tailing factor T is less than or equal to 2; the separation degree of the radioactive main peak and the radioactive impurity peak of the sample illumination solution is more than 1.5, which shows that the system applicability is good. In the ultraviolet chromatogram, the theoretical plate number n of the main peak is more than or equal to 2000;6 samples are tested, the retention time RSD of a main peak is 0.04%, the peak area RSD is 0.97%, and the tailing factor T is less than or equal to 2; the separation degree of the main peak and the adjacent impurity peak of the sample illumination solution is more than 1.5, which shows that the system applicability is good.
TABLE 2
(2) System applicability investigation for chemical content detection
Investigation of the target: taking blank solvent, matrix solution, reference substance solution, and sample solution of sample illumination, respectively sampling 1 needle, and continuously sampling 6 needles.
Inspection standard: the theoretical plate number n of the main peak is more than or equal to 2000;6 needles of the sample to be tested, the retention time of the main peak and the peak area RSD are less than or equal to 5.0 percent; the tailing factor T is less than or equal to 2; the separation degree of the main peak and the adjacent impurity peak of the sample illumination solution is more than 1.5.
The experimental results are shown in Table 3, and the results show that in the ultraviolet chromatogram, the number n of theoretical plates of the main peak is more than or equal to 2000;6 samples were tested, the retention time RSD of the main peak was 0.04%, and the peak area RSD was 0.97%; the tailing factor T is less than or equal to 2; the separation degree of the main peak and the adjacent impurity peak of the sample illumination solution is more than 1.5; the system has good applicability.
TABLE 3 Table 3
In conclusion, the high separation degree (more than 1.5) proves that the detection method has good specificity, the larger theoretical plate number (n is more than or equal to 2000) proves that the detection method has good column efficiency, the small tailing factor (less than or equal to 2) proves that the peak shape is good, and the peak area and the retention time RSD value in the repeatability experiment are smaller, so that the detection method has higher precision.
Example 2
This example provides a fluorine [ 18 F]The steps of the detection method of the betazine injection are only different from those of the embodiment 1: gradient elution was performed according to the procedure in table 4.
TABLE 4 Table 4
The detection results are as follows.
The ultraviolet signal chromatogram of the control is shown in fig. 4, and the result shows that the retention time of the control is 10.612 minutes and the peak area is 2.263mAU min. The control is non-radioactive and therefore has no response to radioactive signals.
The ultraviolet signal chromatogram of the sample is shown in fig. 5, and the result shows that the impurity peak is far away from the main peak (peak 3), the separation degree of the main peak and the impurity peak and each impurity peak is more than 1.5, and the content of the sample can be further calculated according to the concentration of the reference substance, the peak area and the main peak area of the sample.
As shown in FIG. 6, the radioactive signal chromatogram of the sample has a main peak (peak 8) retention time of 10.78 minutes, and fluorine is obtained by peak area normalization 18 F]The radiochemical purity of the betazine is 97.16%, and the separation degree of each impurity peak in the sample is more than 1, so that the impurities can be further researched.
The experimental results show that compared with example 1, only the peak-out time is changed in example 2, and the separation degree between the peaks still meets the analysis requirement.
Comparative example
This comparative example provides a fluorine [ 18 F]The steps of the detection method of the betazine injection are only different from those of the embodiment 1: gradient elution was performed according to the procedure in table 5.
TABLE 5
The detection results are as follows.
The ultraviolet signal chromatogram of the control is shown in fig. 7, and the result shows that the retention time of the control is 20.173 minutes and the peak area is 2.832maχmin. The reference substance has poor peak shape and asymmetric peak shape, and the reference substance has no radioactivity, so the reference substance has no radioactive signal response.
The ultraviolet signal chromatogram of the sample is shown in fig. 8, and the result shows that the adjacent impurity peak (or baseline) and the main peak (peak 2) cannot be effectively separated, and thus cannot be quantitatively detected.
As shown in FIG. 9, the radioactive signal chromatogram of the sample shows a main peak (peak 7) retention time of 20.10 minutes, and fluorine is obtained by peak area normalization 18 F]The radiochemical purity of the betazine is 96.39%, and the separation degree of each impurity peak in the sample is more than 1, so that the impurities can be further researched.
Experimental results show that the detection method of the comparative example cannot quantitatively detect the sample, and the separation degree between the main peak and the adjacent impurity peaks does not meet the analysis requirement.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (10)
1. Fluorine [ 18 F]The detection method of the betazine injection is characterized by comprising the following steps:
separation of fluorine by chromatography column using octadecylsilane chemically bonded silica packing 18 F]Betazine injection;
wherein the mobile phase A is 8-12 mM ammonium acetate solution; mobile phase B is acetonitrile;
the gradient elution procedure was as follows:
the sum of the volume percentages of the mobile phase A and the mobile phase B in each stage is 100 percent;
the volume percentage of mobile phase A at each stage is as follows:
。
2. the detection method according to claim 1, wherein the column temperature of the chromatographic column is 25-35 ℃;
and/or the flow rate of the mobile phase is 0.5-1.5 mL/min.
3. The method according to claim 1, wherein the sample after the gradient elution is detected by an ultraviolet detector.
4. The method of claim 1, wherein the gradient eluted sample is detected using a diode array detector.
5. The method of claim 1, wherein the gradient eluted sample is detected using a radioactive flow detector.
6. The method according to claim 1, wherein the sample after gradient elution is detected by using an ultraviolet detector and a radioactive flow detector;
or detecting the sample after gradient elution by using a diode array detector and a radioactive flow detector.
7. The method according to claim 3 or 4, further comprising: fluorine para-using external standard method 18 F]Fluoro [ in beta-oxazine injection 18 F]The chemical content of the betazine is determined.
8. The method of detecting according to claim 5, further comprising: fluorine is normalized by peak area 18 F]And detecting the radiochemical purity of the betazine injection.
9. The detection method according to claim 3, 4 or 6, wherein the detection wavelength of the ultraviolet detector or the diode array detector is 360 to 370nm.
10. The detection method according to any one of claims 1 to 9, wherein the detection method is performed on fluorine [ 18 F]Application of the betazine injection in quality inspection of products.
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