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Validation of the method to use HPLC for determination for identity and radiochemical purity of 18F-NaF radiopharmaceutical produced at 108 Hospital
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Abstract
SUMMARY
Objective: This study was aimed to standardize the method of determining identity and radiochemical purity of 18F-NaF
according to European Pharmacopoeia and to adapt it to the quality control system of the Cyclotron center at 108 Hospital.
Material and Methods: Agilent 1200 HPLC connected to Carbopac PA10 collumn from Dionex, UV detector and radioactive detector, injector with a multiport valve and a 20μL calibrated loop; Satorius analytical balance with accuracy 0.001g; NaOH from Merk; standard NaF from ABX; ultrapure water from Millipore Milli-Q system. The identification of 18F-NaF is done on HPLC by comparing the retention time (tR) by the radiochemical detector, and tR of the NaF reference UV detector. We determined the difference
between the detectors expressed in time and then correct the tR of 18F-NaF peak. After this, we determined the difference between
corected tR of 18F-NaF and tR of NaF expressed in minute and the percentage deviation of the corrected value of 18F-NaF from the reference NaF.
Results: The results met all requirements in the ICH Q2(R1) guidelines. The calibration curve (0,125-5 mg/ml NaF) had R2 for peak area and height againt concentration are 0.998 and 0.997 respectively. The precision with sample of 1,95 mg/ml NaF has R2 <
5%. The acuracy has the percent recovery from 98.97-100.21% with R2> 0,99 and RSD < 2%. The robustness has RSD = 0.31% < 2%.
Validaion of identity and radiochemical purity test of 8F-NaF showed that the deviation of retention time NaF and 18F-NaF was 0,12-
0,52%; the linearity of the radiochemical purity test had R2 >0,99; the precision of the HPLC method was expressed in results of 5 times of measurement of a 18F-NaF sample, that gave RSD = 0,29%.
Conclusion: The results of the study show that the HPLC 1200 can give an accuracy and reliability for analysis of radiochemical purity and identity tests of 18F-NaF that is under studying at 108 Hospital.
Article Details
Keywords
NaF, 18F-NaF, HPLC, radiopharmaceutical purity
References
1. Sodium (18F) injection. The European Pharmacopoeia. 8th ed. Strasbourg, France: European Directorate for the Quality of the Medicines, 2014, pp.1052 – 1054
2. Shankar Vallabjosula, 18F-labeled positron Emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanism of tumor localization, Seminars in Nuclear Medicine, 37, pp.400-419
3. Blau M, Nagler W, Bender MA (1962), “Fluorine-18: a new isotope for bone scanning. J Nucl Med”, 3, pp. 332–334. [18F]fluoride ion and PET”, J Comput Assist Tomogr, 17, pp. 34–41
4. Steven S. Zigler, Ph.D, New PET Radiopharmaceuticals: Challenges in the Development of Analytical Methods;
VOLUME 14, LESSON 3; The University of New Mexico Health Sciences Center College of Pharmacy; 2008. Mechanisms and Applications, Journal of Nuclear Medicine, 54, 2013, pp. 590-599
5. A. Chopra, L. Shan, W.-C. Eckelman, K. Leung, Important parameters to consider for the characterization of PET and SPECT imaging probes, Nuclear Medicine and Biology, 38, 2011, pp. 1079-1084
6. G.B. Saha, Synthesis of PET radiopharmaceuticals, In: Basics of PET Imaging Physics, Chemistry, and Regulations, Springer, New York, 1-18; 2004, pp. 111–124
7. C.-C. Li,S.-S. Farn, Y.-H. Yeh, W.-J. Lin, L.-H. Shen, Development and validation of an anionexchange HPLC
method for the determination of fluoride content and radiochemical purity in [18F] NaF, Nuclear Medicine and
Biology, 38, 2011, pp. 605-612
8. M.N. Leonardi, G.-A. Casale, J. Nicolini, P.-D. Zubata, M.-J. Salgueiro, M.-B. Zubillaga, Validation of a paper chromatographic methodology as an alternative for determination of the radiochemical purity of Na18F, Journal
of Nuclear Medicine Technology, 40, 2012, pp. 271-274
9. ***Validation of Analytical Procedures: Text and Methodology, Q2(R1), ICH Harmonised tripartite guideline, 2005
10. I. Ion, D. Bogdan, A.-C. Ion, Improvement in the determination of traces of nitrate and nitrite in natural mineral waters by ion chromatography, U.P.B. Sci. Bull., 76, 2014, pp.112-122