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A thin-layer chromatographic analysis method for radiochemical purity of sodium fluoride [18f] injection

A technology of thin-layer chromatography and analysis method, which is applied in the field of thin-layer chromatography analysis of radiochemically pure sodium fluoride [18F] injection, can solve the problems of no separation of impurities and no effective expansion, etc., and achieve the effect of rapid detection

Active Publication Date: 2019-01-29
HTA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Nandy et al reported the determination of fluorine by thin layer chromatography [ 18 F] sodium chloride injection radiochemically pure method, but this report adopts silica gel plate as stationary phase, and 95% acetonitrile is as mobile phase, and the main peak of radioactivity is basically at the origin, R f The value is 0.0‐0.12, which is not effectively developed, and there is a possibility that some impurities are not separated

Method used

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  • A thin-layer chromatographic analysis method for radiochemical purity of sodium fluoride [18f] injection
  • A thin-layer chromatographic analysis method for radiochemical purity of sodium fluoride [18f] injection
  • A thin-layer chromatographic analysis method for radiochemical purity of sodium fluoride [18f] injection

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Comparison scheme
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Embodiment 1

[0034] Different materials were used as stationary phases and corresponding mobile phases were used for screening. The results are shown in Table 1. It can be seen from the data in the table that the systems 11, 14, and 21 can remove impurities and fluorine [ 18 F] Sodium chloride is effectively separated, and the R of the two peaks f The value is also more appropriate, but the tailing of systems 11 and 21 is more serious, so it is finally determined that the best TLC conditions are: the stationary phase is Whatman No.1, and the mobile phase is V (methanol): V (water) = 20:20 Expand the system.

[0035] Table 1 TLC results of different expansion systems

[0036]

[0037]

Embodiment 2

[0039] After analysis using system 14, it can be seen that the main peak has a tailing phenomenon on the chromatographic paper, and the peak is slightly wider. In order to get a better peak shape and improve tailing, try to add acid or alkali to the developing system, adjust the pH of the developing agent, and observe the developing situation. The results are listed in Table 2. figure 1 and figure 2 . According to the analysis, the tailing is slightly improved in the alkaline system, and the preferred mobile phase is V (methanol): V (water): V (0.05mol / LNaOH) = 20:20:1. The fluoride impurity peak becomes smaller in the acidic system, which may be due to the reaction of some fluoride impurities with the acid, and the main product fluorine[ 18 F] Sodium chloride unfolds together to the leading edge.

[0040] Table 2 The influence of different pH values ​​of the same expansion system on the results of TLC analysis

[0041]

Embodiment 3

[0043] The present invention treats Whatman No.1 chromatographic paper with the following several electrolyte solutions, with V (methanol): V (water) = 20: 20 development system is mobile phase respectively to fluorine [ 18 F] sodium chloride radiochemically pure for analysis. 1) a sodium acetate solution with a mass percentage concentration of 1%; 2) a mass percentage concentration of 1% aluminum potassium sulfate solution; 3) a mass percentage concentration of 0.9% sodium chloride solution; 4) a mass percentage concentration 1% sodium carbonate solution; 5) 1% sodium bicarbonate solution. The corresponding chromatogram is as image 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 shown. It can be seen from the figure that the development effect of Whatman No.1 chromatographic paper is the best after treatment with sodium acetate, sodium chloride and sodium carbonate solution, which can effectively reduce tailing, and the development effect with sodium ace...

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Abstract

The invention belongs to the field of thin layer chromatography analysis, and particularly relates to a thin layer chromatography analysis method for radiochemical purity of a sodium fluoride [<18>F] injection. The method comprises the following steps that (1) sample application is performed at 2-3cm of one end of a stationary phase subjected to electrolyte solution treatment; (2) airing is performed and then the stationary phase is placed in a saturate tank filled with a mobile phase to allow a sample application end of the stationary phase to be immersed into a developer for about 1-2cm; (3) the stationary phase is taken out when the front of the developer reaches 8-10cm and then cold air drying is performed by a blower; (4) radioactive counting is measured on a radioactive chromatographic scanner and an Rf value and the radiochemical purity are calculated; and (5) an appropriate condition is selected according to the Rf value and a peak shape of a main peak. A used electrolyte solution is one of a sodium acetate solution with mass percent concentration of 1-3%, an aluminium potassium sulfate solution, a sodium chloride solution, a sodium carbonate solution and a sodium bicarbonate solution. With the adoption of the technical scheme, the Rf value of the radioactive main peak can be expanded to 0.7-0.8; and [<18>F] and other radioactive impurities can be effectively separated.

Description

technical field [0001] The invention belongs to the field of thin-layer chromatography analysis, in particular to a fluoro[ 18 F] Thin-layer chromatographic analysis method for radiochemical purity of sodium chloride injection. Background technique [0002] fluorine[ 18 F] sodium chloride injection is a positron emission tomography (Positron EmissionTomography, PET) drug, mainly used for the diagnosis of active osteogenic reaction bone disease. As early as 1962 Blau et al. ] It was found to be an excellent bone imaging agent, approved by the U.S. Food and Drug Administration (FDA) in 1972 18 F‐sodium fluoride injection was used clinically, but the market supply was suspended in 1975 due to commercial reasons. In recent years, due to the rapid development of PET and PET / CT technology, 18 The superiority of F‐sodium fluoride PET imaging and 99 Mo / 99 Tc m generator 99 The global supply shortage of Mo raw materials, the international 18 The research and application of...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/95
CPCG01N30/90G01N30/95
Inventor 郭飞虎姜华叶肇云李梓石伟成伟华尹长峰樊红强
Owner HTA CO LTD