Validation of a cost-effective alternative for a radiochromatography method to be used in a developing country
Date
2020-04-10
Journal Title
Journal ISSN
Volume Title
Publisher
SpringerOpen (part of Springer Nature)
Abstract
Introduction: The radiochemical purity (RCP) of technetium-99m labelled
radiopharmaceuticals (RP) is important to ensure optimal scintigraphic image quality.
In low-income settings, it may not be possible to use compendial analytical methods
or expensive equipment for radiochemical purity analysis. All radiochemical analysis
methods should however be validated against compendial or otherwise proven
methods. To ensure the efficacy of RP prepared at Yaoundé General Hospital (YGH)
Cameroon, this study cross-validated a cost-effective routine chromatographic
method using a simple survey meter technique. A GMP-compliant method used at
the University Medical Center Groningen (UMCG), the Netherlands was used as the
comparator.
Methods: Sestamibi, HMDP and DMSA kits currently used at YGH were reconstituted
at UMCG with about 2000 MBq of freshly eluted sodium pertechnetate as described
by the manufacturer, and spiked with eluate of the same generator to obtain a
range of impurity concentrations. Samples of technetium-99m RP were spotted on
1 × 10 cm iTLC-SG strips and developed in appropriate mobile phases. Each strip was
first scanned on the chromatogram-scanner used at the UMCG (standard method),
and immediately thereafter the strip was cut in two pieces and radioactivity from
each portion was counted with a small survey meter from YGH. The percentage RCP
for each TLC strip was calculated using both counting methods. Internationally
recommended validation parameters and acceptance criteria were used. Student’s
paired t-test or ANOVA were used with ‘no significant difference’ designated at a
95% confidence-interval (P ≥ 0.05). Linearity of the survey meter was determined for
Tc-99m. Readings obtained with the survey meter were also plotted against the
scanner results.
Results and discussion: The proposed method proved to be accurate (CV of mean
RCP < 2), precise (RSD < 2%), linear (slope close to 1, r2 ≥ 0.99) within the RCP range
of approximately 80% to 100%, and robust (P > 0.05). LOD and LOQ were determined
for the survey meter. Specificity depends on chemical separation. As we were validating the suitability of a method to quantify radioactivity, specificity was not
included in the validation parameters. Conclusion: The proposed method compared well with the standard method and is
suitable as a reliable low cost method for limited resource settings.
Description
CITATION: Ekoume, F. P., et al. 2020. Validation of a cost-effective alternative for a radiochromatography method to be used in a developing country. EJNMMI Radiopharmacy and Chemistry, 5:9, doi:10.1186/s41181-020-0092-1.
The original publication is available at https://ejnmmipharmchem.springeropen.com
The original publication is available at https://ejnmmipharmchem.springeropen.com
Keywords
Radiochemistry -- Research, Radiochromatography, Radiochemical analysis, Quality control, Developing countries
Citation
Ekoume, F. P., et al. 2020. Validation of a cost-effective alternative for a radiochromatography method to be used in a developing country. EJNMMI Radiopharmacy and Chemistry, 5:9, doi:10.1186/s41181-020-0092-1