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J Nucl Med. 2008; 49 (Supplement 1):304P
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Radiopharmaceutical Chemistry: Radiopharmacy

Radiopharmacy Posters

Development of an integrity assay method of SMPY by HPLC and LC-MS/MS

Kung-Tien Liu1, Hang-Hsing Yang1, Yi-Chih Hsia1, Hui-Yin Tsai1, Chia-Chieh Chen1 and Lie-Hang Shen1

1 Radiation Application Technology Center, Institute of Nuclear Energy Research, Taoyuan County, Taiwan

1296

Objectives: I-123-IMPY is a thioflavin-T derivative probe for in vivo SPECT imaging of beta-amyloid plaques in patients of Alzheimer’s disease. SMPY is the precursor of IMPY. In the present study, we developed an integrity assay method for structure determination, multiple reaction monitoring transition, purity and bench-top stability of SMPY for the purpose of pharmaceutical quality control.

Methods: Purity assay was achieved using an Agilent 1100 HPLC. Structural determination was carried out by product ion scan and precursor ion scan using an API 4000 QTrap ESI-MS/MS. A C-18 column was employed with an eluent consisting of ammonium acetate buffer (10 mM, pH 7.0), methanol and acetonitrile. The detection wavelength was 230 nm.

Results: Under the optimal conditions, retention time of SMPY was 3.45 ± 0.00 min (RSD = 0.04%). Major impurities with retention time of 2.85 min, 3.00 min and 14.09 min in SMPY were found. Purity of SMPY was 98.08% ± 0.94% (RSD = 0.96%). The calibration plot of peak area against SMPY concentration showed good linearity over the concentration range 20 – 400 ppm. A linear regression equation of y = 3650x – 72 with a correlation coefficient of 0.9991 was achieved. The chromatographic resolution between SMPY and the nearest impurity was 2.94. Bench-top stability, which was determined by average purity of SMPY for three consecutive days was 97.12% ± 0.12% (RSD = 0.13%). No significant degradation was observed within three days. Major fragments of SMPY were found at m/z 358.5, 238.5, 222.0, 194.4, 159.0, 134.0, 117.0 and 91.0.

Conclusions: An integrity assay method of SMPY was well developed. Validation parameters, including precision, linearity and solution stability were shown to be a good method for pharmaceutical QC.

Research Support: The grant was supported by Executive Yuan, Taiwan.





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