CN115112808A - Measuring iodine [ 2 ] 131 I]Method for chemical purity of iodide and radioactivity in sodium solution - Google Patents
Measuring iodine [ 2 ] 131 I]Method for chemical purity of iodide and radioactivity in sodium solution Download PDFInfo
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- CN115112808A CN115112808A CN202210746096.0A CN202210746096A CN115112808A CN 115112808 A CN115112808 A CN 115112808A CN 202210746096 A CN202210746096 A CN 202210746096A CN 115112808 A CN115112808 A CN 115112808A
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- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
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Abstract
The invention discloses a method for measuring iodine 131 I]A method for chemical purity of iodide and radioactivity in a sodium solution, comprising the steps of: preparation of measuring iodine [ iodine ], [ 131 I]The chemical purities of iodide and radioactivity in the sodium solution are simultaneously suitable for a test solution and a control solution; the ultraviolet detector is connected in series with the radioactivity detector, and the iodine in the test solution and the reference solution in the previous step is measured simultaneously 131 I]The chemical purities of iodide and radioactivity in the sodium solution are reduced, the salt effect in the previous step is reduced, the introduction of a system chromatographic peak is avoided, the difference of retention time of the iodide in the test solution and the iodide in the reference solution in an ultraviolet detector and a radioactivity detector is reduced, the interference of other impurities is eliminated, the attribution of the chromatographic peak is convenient to confirm, and the problems that the existing iodide and the sample solution used for measuring the radiochemical purities are different, and the used solvents are different, so that the iodine is caused 131 I]Dissolving in sodium solution [ I ‑ ]And radioactive chemical purity of "Zhonghua 131 I ‑ ]Difficult to be accurately characterized.
Description
Technical Field
The invention relates to a detection method, in particular to the measurement of iodine [ 2 ] 131 I]The chemical purity of iodide and radioactivity in sodium solution.
Background
Iodine in China pharmacopoeia 2020 edition and United states pharmacopoeia 43 edition 131 I - ]The sodium iodide solution has no iodide examination item, the radioactive chemical purity is separated from different chemical substances by adopting a paper chromatographic separation technology, the radioactivity of each chemical substance is measured by using a proper radioactivity measuring instrument, and the radioactive detector which is serially connected with a high performance liquid chromatography radioactive detector and an ultraviolet detector is used for measuring the iodide and radioactive chemical purity on line in the European pharmacopoeia.
Chromatographic parameters of instruments and the like in the analysis method of the chemical purity of iodide and radioactivity carried in European pharmacopoeia 10.0 are the same, but sample solutions of two items are different and need to be prepared respectively, and [ I ] obtained under an ultraviolet detector - ]Retention time and radioactivity detection 131 I - ]The retention time difference is large, and if other impurities exist, the assignment of the chromatographic peak is difficult to judge, so that the iodine is caused 131 I]Dissolving in sodium solution [ I - ]And radioactive chemical purity of "Zhonghua 131 I - ]Difficult to be accurately characterized.
Disclosure of Invention
The technical problem to be solved by the invention is that the prior iodide is different from the solution of the sample used when the radiochemical purity is measured, and the used solvents are different, so that the iodine is difficult to be accurately measured 131 I]The chemical purity of iodide and radioactivity in the sodium solution is to provide the measurement of iodine 131 I]The method of iodide and radioactive chemical purity in sodium solution solves the problems of different solutions and different solvents of iodide and radioactive chemical purity in the prior art, which lead to iodine [ p ], [ solution ] and radioactive chemical purity 131 I]Dissolving in sodium solution [ I - ]And radioactive chemical purity of "Zhonghua 131 I - ]Difficult to be accurately characterized.
The invention is realized by the following technical scheme:
measuring iodine [ 2 ] 131 I]A method for chemical purity of iodide and radioactivity in a sodium solution, comprising the steps of:
s1: preparation of measuring iodine [ iodine ], [ 131 I]The sample solution suitable for both chemical purities of iodide and radioactivity in the sodium solution is used for preparing the measuring iodine 131 I]A control solution for simultaneously using the chemical purities of iodide and radioactivity in the sodium solution;
s2: the ultraviolet detector is used in series with the radioactivity detector, and iodine in the sample solution is simultaneously measured at S1 131 I]Chemical purity of iodide and radioactivity in the sodium solution;
s3: the salt effect in S1 and S2 is reduced, the introduction of a system chromatographic peak is avoided, so that the difference between the retention time of iodide in a test solution and a reference solution in an ultraviolet detector and a radioactive detector is reduced, the interference of other impurities is eliminated, and the attribution of the chromatographic peak is convenient to confirm;
s4: the influence of salt effect in the carrier solution is reduced, the mobile phase baseline is stable, the signal-to-noise ratio of a chromatographic peak obtained by the radioactive detector is improved, and the detection sensitivity of the chromatographic peak is improved.
The working principle of the invention is as follows: when the prior iodide and radioactive chemical purity are measured, the prepared reference solution is different from the solvent used by the test solution, which causes difficulty in accurately assigning iodine [ 2 ] 131 I]The iodide chromatographic peak in the sodium iodide solution, and in order to solve the above-mentioned technical problems, the measurement of iodine is now established 131 I]Method for chemical purity of iodide and radioactivity in sodium solution, and method for preparing and measuring iodine [ iodine ], [ solution of iodine and radioactivity ] 131 I]The sample solution suitable for both chemical purities of iodide and radioactivity in the sodium solution is used for preparing the measuring iodine 131 I]The reference solution with iodide and radioactive chemical purities in the sodium solution suitable for use simultaneously adopts a high performance liquid chromatography radioactive detector and an ultraviolet detector connected in series, so that the iodine [ 2 ] is measured 131 I]The two items of the chemical purity of iodide and radioactivity in the sodium solution can be checked at the same time, so that the method is convenient for operationIn autoinjection, detect, shorten analysis time greatly, also reduced the risk that the instrument and equipment is polluted by the radioactivity simultaneously, avoided the risk that produces a large amount of radioactive liquid wastes among the testing process.
The existing European pharmacopoeia method adopts untreated test solution as liquid to be detected, has high sample activity and great health risk to detection personnel, and adopts diluted iodine 131 I]The sodium hydroxide solution of sodium chloride is used as a test solution, reduces the health risk and simultaneously needs iodine 131 I]The sodium dissolving solution has less sample amount, and the detection method is suitable for iodine [ 2 ] 131 I]Sodium dissolving solution, iodine [ alpha ], [ alpha ] and [ alpha ] an 131 I]Sodium iodide oral solution and iodine 131 I]Sodium dissolving capsule and capsule containing the same 131 I]The radiopharmaceutical reduces the salt effect in the test solution and the contrast solution, avoids introducing a system chromatographic peak, reduces the difference of retention time of iodides in the test solution and the contrast solution in an ultraviolet detector and a radioactive detector, eliminates the interference of other impurities, and is convenient for confirming the attribution of the chromatographic peak; reduce the influence of salt effect in the carrier solution, stabilize the base line of the mobile phase, improve the signal-to-noise ratio of the chromatographic peak obtained by the radioactive detector, improve the detection sensitivity of the chromatographic peak, and solve the problems that the prior iodide is different from the sample solution used in the radioactive chemical purity measurement, and the used solvents are different, thereby causing the iodine 131 I]Dissolving in sodium solution [ I - ]And radioactive chemical purity of "Zhonghua 131 I - ]Difficult to be accurately characterized.
Further, the sample solution is iodine [ iodine ], [ solution of iodine ] 131 I]A sodium hydroxide solution of sodium, by the amount of iodine [ 2 ] 131 I]The sodium hydroxide solution of sodium iodide is convenient for detecting iodine 131 I]The chemical purities of iodide and radioactivity in the sodium solution are simultaneously suitable, and the detection of iodine is avoided 131 I]Different sample solutions are required to be prepared for chemical purities of iodide and radioactivity in sodium solution, the contrast solution comprises potassium iodide and potassium iodate, and detection of iodine is facilitated by the arranged mixed contrast solution of potassium iodide and potassium iodate[ 131 I]The chemical purities of iodide and radioactivity in the sodium solution are simultaneously suitable, and the iodine detection is avoided 131 I]The chemical purity of iodide and radioactivity in the sodium solution requires the preparation of different control solutions.
Furthermore, the radioactive detector is a high performance liquid chromatography radioactive detector, adopts the high performance liquid chromatography radioactive detector for automatic sample introduction and detection, adopts the ultraviolet detector to be connected with the high performance liquid chromatography radioactive detector in series, and is convenient for simultaneously measuring the iodine in the test solution 131 I]The chemical purities of iodide and radioactivity in the sodium solution are convenient for simultaneously measuring iodine in the control solution 131 I]Iodide and radioactivity in sodium solution are of chemical purity.
Furthermore, the radioactive concentration of the iodide in the test solution and the control solution is more than or equal to 2.5mCi/ml, and the radioactive concentration of the iodide in the test solution and the control solution and the radioactive chemical purity in the test solution and the control solution are set, so that the iodine in the test solution and the control solution can be accurately detected conveniently 131 I]The chemical purity of iodide and radioactivity in the sodium solution is improved, and the radioactive concentration of iodide in the test solution and the control solution and the radioactive chemical purity of the test solution and the control solution are prevented from being too high to cause radioactive radiation hazard to detection personnel.
Furthermore, the diluents in the test solution and the control solution are ultrapure water, the detection method simplifies the operation, a carrier solvent is not required to be prepared, and the diluent solvent is only ultrapure water, so that the use of chemical reagents is saved.
Furthermore, the lead screen is adopted to surround the periphery of the ultraviolet detector and the radioactive detector, and meanwhile, the lead screen is adopted to effectively shield the ultraviolet detector and the radioactive detector, so that the contact time of detection personnel to radioactive samples is reduced, the dose of the detection personnel irradiated by radioactivity is effectively reduced, and the health of the detection personnel is guaranteed.
Compared with the prior art, the invention has the following advantages and beneficial effects:
1. the present invention measures iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and [ alpha ] an 131 I]The method for chemical purity of iodide and radioactivity in the sodium solution is optimized on the basis of the European pharmacopoeia loading analysis method, and the obtained detection method is simple and convenient to operate, and the accuracy and the precision of a measured result are good;
2. the present invention measures iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and [ alpha ] an 131 I]The method for chemical purity of iodide and radioactivity in the sodium solution has the advantages of strong specificity, high accuracy, good density and high sensitivity;
3. the present invention measures iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and [ alpha ] an 131 I]The method for chemical purity of iodide and radioactivity in sodium solution uses diluted iodine 131 I]The sodium hydroxide solution of sodium chloride is used as a test solution, reduces the risk of health of detection personnel, and simultaneously, the required iodine [ iodine ], [ solution ] 131 I]The sample amount of the sodium dissolving solution is less, so that great economic cost is saved in the detection process.
Drawings
The accompanying drawings, which are included to provide a further understanding of the embodiments of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the principles of the invention. In the drawings:
FIG. 1 is a detection diagram of the method of the present invention;
fig. 2 is a detection diagram of a prior art EP9.0 method.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to examples and accompanying drawings, and the exemplary embodiments and descriptions thereof are only used for explaining the present invention and are not meant to limit the present invention.
Example 1
The present invention measures iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and [ alpha ] an 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is shown in figure 1.
The specific implementation manner of this embodiment is:
control solution:
precisely weighing 26.2mg of potassium iodide reference substance and 24.5mg of potassium iodate reference substance, placing in a 1000ml measuring flask, dissolving with water, diluting to scale, shaking, and refiningWeighing 10ml, placing in 100ml measuring flask, diluting with water to scale, and shaking to obtain a solution containing [ I ] per 1ml - ]2.0. mu.g, [ IO ] 3 - ]The amount of the control solution was 2.0. mu.g.
Test solution:
precisely measuring a sample (1000mCi/ml iodine [ iodine ], [ solution of iodine ] in a predetermined amount 131 I]The sodium chloride solution is pre-diluted to 10mCi/ml) by water to 0.25ml, and is quantitatively diluted to 1.0ml by water and mixed evenly.
Control solution:
precisely measuring 0.125ml of reference solution and 0.25ml of test solution (pre-diluted to 10mCi/ml), quantitatively diluting with water to 1.0ml, and shaking.
Chromatographic conditions are as follows:
octadecylsilane chemically bonded silica was used as a packing material (4.6 mm. times.250 mm, 5 μm or equivalent performance column); the mobile phase is a mixed solution of sodium chloride buffer solution and acetonitrile (5.48 g of sodium chloride is taken and dissolved in 1000ml of water, 0.65ml of n-octylamine is added, the pH value is adjusted to 7.0 by phosphoric acid solution, 50ml of acetonitrile is added and mixed evenly); flow rate was 1.5ml per minute; the column temperature is 30 ℃; the detection wavelength is 220 nm; the sample amount is 25 mul; the collection time is 20 min.
The measurement method comprises precisely measuring the sample solution and the control solution, respectively injecting into a liquid chromatograph, and recording chromatogram.
In the UV detection chromatogram of the limit test solution, the peak area of iodide should not exceed 0.5 times of the peak area of iodide in the control solution (i.e., 1000mCi/ml iodine [, ]) 131 I]Dissolving in sodium solution [ I - ]Should be less than or equal to 100 mug/ml).
In the A2D detection chromatogram of the test solution, iodine is calculated by the peak area normalization method 131 I]The peak area of the compound must not be less than 95%.
Example 2
Based on the embodiment 1, as shown in figures 1-2.
The specific implementation manner of this embodiment is: the method is used for preparing and measuring iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and [ alpha ], [ alpha ] and a 131 I]The sample solution suitable for both chemical purities of iodide and radioactivity in the sodium solution is used for preparing the measuring iodine 131 I]Iodide and radiochemistry in sodium iodide solutionsThe contrast solution with simultaneously applicable purity adopts a high performance liquid chromatography radioactivity detector and an ultraviolet detector which are connected in series, so that the iodine is measured 131 I]The two project inspections of iodide and radiochemical purity in the sodium dissolving solution can be completed simultaneously, so that automatic sample introduction and detection are facilitated, the analysis time is greatly shortened, the risk that the instrument and equipment are polluted by radioactivity is reduced, and the risk that a large amount of radioactive waste liquid is generated in the detection process is avoided.
The existing European pharmacopoeia method adopts untreated test solution as liquid to be detected, has high sample activity and great health risk to detection personnel, and adopts diluted iodine 131 I]The sodium hydroxide solution is used as a test solution, reduces the health risk and simultaneously needs iodine 131 I]The sodium dissolving solution has less sample amount, and the detection method is suitable for iodine [ 2 ] 131 I]Sodium dissolving solution, iodine [ alpha ], [ alpha ] and [ alpha ] an 131 I]Sodium iodide oral solution and iodine 131 I]Sodium dissolving capsule and capsule containing the same 131 I]The radiopharmaceutical reduces the salt effect in the test solution and the contrast solution, avoids introducing other unknown chromatographic peaks, reduces the difference of the retention time of iodides in the test solution and the contrast solution in an ultraviolet detector and a radioactive detector, eliminates the interference of other impurities, and is convenient for confirming the attribution of the chromatographic peaks; reduce the influence of salt effect in the carrier solution, stabilize the base line of the mobile phase, improve the signal-to-noise ratio of the chromatographic peak obtained by the radioactive detector, improve the detection sensitivity of the chromatographic peak, and solve the problems that the prior iodide is different from the sample solution used in the radioactive chemical purity measurement, and the used solvents are different, thereby causing the iodine 131 I]Dissolving in sodium solution [ I - ]And radioactive chemical purity of "Zhonghua 131 I - ]Difficult to be accurately characterized.
Example 3
Based on the above-described embodiments, as shown in fig. 1-2.
The specific implementation manner of this embodiment is: the sample solution is iodine 131 I]Dissolving sodium in sodium hydroxide solution byThe iodine [ alpha ], [ alpha ] and [ alpha ], [ alpha ] is 131 I]The sodium dissolving solution is convenient for detecting iodine 131 I]The chemical purities of iodide and radioactivity in the sodium solution are simultaneously suitable, and the detection of iodine in EP9.0 is avoided 131 I]The chemical purities of iodide and radioactivity in the sodium solution need to be configured with different sample solutions, the control solution comprises potassium iodide and potassium iodate, and the detection of iodine is facilitated by the arranged potassium iodide and potassium iodate mixed control solution 131 I]The chemical purities of iodide and radioactivity in the sodium solution are simultaneously suitable, and the detection of iodine is avoided 131 I]Different control solutions are required to be prepared for the chemical purities of iodide and radioactivity in the sodium solution.
The radioactivity detector is a high performance liquid chromatography radioactivity detector, adopts the high performance liquid chromatography radioactivity detector for automatic collection and detection, adopts the ultraviolet detector to be connected with the high performance liquid chromatography radioactivity detector in series, and is convenient for simultaneously measuring the iodine in the test solution 131 I]The chemical purities of iodide and radioactivity in the sodium solution are convenient for simultaneously measuring iodine in the control solution 131 I]Iodide and radioactivity in sodium solution are of chemical purity.
Example 4
Based on the above embodiment, the specific implementation manner of this embodiment is as follows: the radioactive concentration of the iodide in the test solution and the contrast solution is more than or equal to 2.5mCi/ml, and the iodine in the test solution and the iodine in the contrast solution can be conveniently and accurately detected by setting the radioactive concentration of the iodide in the test solution and the contrast solution and the radioactive chemical purity in the test solution and the contrast solution 131 I]The detection method has the advantages that the operation is simplified, a carrier solvent is not required to be prepared, and the use of chemical reagents is saved because the diluting solvent is only ultrapure water.
Example 5
Based on the above embodiment, the specific implementation manner of this embodiment is as follows: adopt the lead screen to encircle ultraviolet detector and radioactive detector's periphery, adopt the lead screen to carry out effectual shielding to ultraviolet detector and radioactive detector simultaneously, reduce the contact time of detection personnel to the radioactive sample, reduced the dose that detection personnel received the radiation effectively for detection personnel's health is protected.
The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (6)
1. Measuring iodine [ 2 ] 131 I]A method for chemical purity of iodide and radioactivity in a sodium solution, comprising the steps of:
s1: preparation of measuring iodine [ iodine ], [ 131 I]The sample solution with the chemical purities of iodide and radioactivity in the sodium solution being simultaneously suitable is used for preparing the measured iodine 131 I]A control solution for simultaneously using the chemical purities of iodide and radioactivity in the sodium solution;
s2: the ultraviolet detector is used in series with the radioactivity detector, and iodine in the sample solution is simultaneously measured at S1 131 I]Chemical purity of iodide and radioactivity in the sodium solution;
s3: the salt effect in S1 and S2 is reduced, the introduction of a system chromatographic peak is avoided, so that the difference of the retention time of iodide in a test solution and a reference solution in an ultraviolet detector and a radioactive detector is reduced, the interference of other impurities is eliminated, and the attribution of the chromatographic peak is convenient to confirm;
s4: the influence of salt effect in the carrier solution is reduced, the mobile phase baseline is stable, the signal-to-noise ratio of a chromatographic peak obtained by the radioactive detector is improved, and the detection sensitivity of the chromatographic peak is improved.
2. The measurement of iodine [ 2 ] according to claim 1 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is characterized in that the sample solution is iodine [ iodine ], [ solution of iodine ] and/or iodine 131 I]Sodium hydroxide solution, and control solution including potassium iodide solution and potassium iodate solution.
3. The measurement of iodine [ 2 ] according to claim 1 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is characterized in that a radioactive detector is a high performance liquid chromatography radioactive detector, and automatic sample injection and detection are performed by adopting the high performance liquid chromatography radioactive detector.
4. The measurement of iodine [ 2 ] according to claim 1 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is characterized in that the radioactive concentration of iodide in a test solution and a control solution is more than or equal to 2.5 mCi/ml.
5. The measurement of iodine [ 2 ] according to claim 1 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is characterized in that diluents in the test solution and the control solution are ultrapure water.
6. The measurement of iodine [ 2 ] according to claim 1 131 I]The method for chemical purity of iodide and radioactivity in sodium solution is characterized in that lead screens are adopted to surround the peripheries of an ultraviolet detector and a radioactivity detector.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000043110A1 (en) * | 1999-01-22 | 2000-07-27 | Mallinckrodt Inc. | Process for the purification and concentration of radioiodide isotopes |
| US6773686B1 (en) * | 1999-01-22 | 2004-08-10 | Mallinckrodt Inc. | Process for the purification and concentration of radiodide isotopes |
| CN110057963A (en) * | 2019-05-24 | 2019-07-26 | 南京江原安迪科正电子研究发展有限公司 | A kind of Na18The high-efficiency liquid chromatography method for detecting of content of fluoride ion in F injection |
| CN110879270A (en) * | 2019-11-13 | 2020-03-13 | 原子高科股份有限公司 | Fluorine [ 2 ]18F]High performance liquid chromatography analysis method for sodium chloride injection |
-
2022
- 2022-06-28 CN CN202210746096.0A patent/CN115112808A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000043110A1 (en) * | 1999-01-22 | 2000-07-27 | Mallinckrodt Inc. | Process for the purification and concentration of radioiodide isotopes |
| US6773686B1 (en) * | 1999-01-22 | 2004-08-10 | Mallinckrodt Inc. | Process for the purification and concentration of radiodide isotopes |
| CN110057963A (en) * | 2019-05-24 | 2019-07-26 | 南京江原安迪科正电子研究发展有限公司 | A kind of Na18The high-efficiency liquid chromatography method for detecting of content of fluoride ion in F injection |
| CN110879270A (en) * | 2019-11-13 | 2020-03-13 | 原子高科股份有限公司 | Fluorine [ 2 ]18F]High performance liquid chromatography analysis method for sodium chloride injection |
Non-Patent Citations (4)
| Title |
|---|
| EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE: "《European Pharmacopoeia 9th Edition》", 15 January 2017, DRUCKEREI C. H. BECK * |
| J. C. HUNG 等: "Rapid Radiochemical Purity Testing for [131I]m-Iodobenzylguanidine", 《NUCL. MED. BIOL.》 * |
| 张云 等: "放射性药品的放化纯度分析方法概述", 《同位素》 * |
| 杨柳 等: "Radio-HPLC分析方法测定治疗用碘[131I]化钠胶囊的放射化学纯度", 《核化学与放射化学》 * |
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