Rapid radiochemical purity testing for [131I]m-iodobenzylguanidine

Area of Science:

• Radiopharmaceutical chemistry
• Analytical chemistry
• Chromatography techniques

Background:

• The standard high-pressure liquid chromatography (HPLC) method for determining the radiochemical purity (RCP) of [131I]m-iodobenzylguanidine ([131I]mIBG) is complex and lengthy.
• Efficient and accurate purity assessment is crucial for radiopharmaceutical quality control.

Purpose of the Study:

• To develop and validate a simplified, rapid method for determining the RCP of [131I]mIBG.
• To compare the performance of the new method against the established HPLC technique.

Main Methods:

• A reverse-phase extraction chromatography technique using a Sep-Pak C18 (SPC) cartridge was employed.
• The SPC method was used to separate [131I]mIBG from potential impurities.
• Results were compared with those obtained from the standard HPLC method.

Main Results:

• The SPC method provides a significantly faster analysis, completing in less than 5 minutes.
• The results from the SPC method showed a high correlation (r = 0.99) with the standard HPLC method.
• The SPC technique offers a simplified and efficient alternative for RCP determination.

Conclusions:

• The Sep-Pak C18 cartridge method is a viable and rapid alternative for assessing the radiochemical purity of [131I]mIBG.
• This simplified method can improve the efficiency of quality control processes for this radiopharmaceutical.