Analisis Kemurnian Radiokimia Radiofarmaka 99mTc-TRODAT-1 Berdasarkan Evaluasi Kromatografi Lapis Tipis pada Tiga Kelompok Eksperimen
DOI:
https://doi.org/10.69693/ijim.v4i2.985Keywords:
99mTc-TRODAT-1, Kemurnian Radiokimia, Kendali Mutu, ParkinsonAbstract
Radiofarmaka 99mTc-TRODAT-1 merupakan agen pencitraan molekuler Single Photon Emission Computed Tomography yang sangat spesifik untuk mengevaluasi integritas neuron dopaminergik presinaptik melalui ikatan dengan dopamine transporter (DAT). Uji kendali mutu berupa penentuan kemurnian radiokimia (Radiochemical Purity) merupakan tahapan krusial untuk menjamin efikasi pencitraan dan meminimalkan paparan radiasi non-spesifik pada pasien. Penelitian ini bertujuan untuk menganalisis variabilitas kemurnian radiokimia dari tiga kelompok eksperimen formulasi 99mTc-TRODAT-1 menggunakan kromatografi lapis tipis yang dipindai dengan radio-TLC scanner MiniGITA. Metode pemisahan menggunakan sistem fase diam berbasis silika gel dengan fase gerak kombinasi aseton dan NaCl. Hasil eksperimen menunjukkan variabilitas yang signifikan antar-batch: Eksperimen 1 (06/02/2025) menghasilkan RCP sebesar 79,87% (tidak memenuhi syarat); Eksperimen 2 (18/07/2025) menghasilkan pemisahan resolusi tinggi dengan kadar kompleks aktif 95,32%, perteknetat bebas (99mTcO4-) 3,67%, dan koloid 99mTcO2 1,01%; sedangkan Eksperimen 3 (22/01/2026) menunjukkan kemurnian tertinggi sebesar 95,40%. Disimpulkan bahwa optimasi parameter formulasi seperti pH, jumlah reduktor SnCl2, dan waktu inkubasi sangat mempengaruhi keberhasilan radiolabeling, di mana kadar RCP ≥ 90% menjadi prasyarat mutlak sebelum aplikasi klinis pada pasien Parkinson.
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