XÂY DỰNG VÀ THẨM ĐỊNH PHƯƠNG PHÁP PHÂN TÍCH TỒN DƯ DUNG MÔI ACETONITRILE TRONG SẢN PHẨM DƯỢC CHẤT PHÓNG XẠ 18F-FDG BẰNG SẮC KÝ KHÍ

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Tác giả: Thị Tâm Đàm, Thị Thu Hiền Lê, Đức Minh Mai, Văn Vinh Mai, Thị Thu Thủy Ngô, Quang Anh Nguyễn, Mạnh Thắng Trần

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Thông tin xuất bản: Tạp chí Khoa học & Công nghệ - Trường Đại học Công nghiệp Hà Nội, 2022

Mô tả vật lý: tr.134

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ID: 337743

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Dược chất phóng xạ (DCPX) 18F-FDG có thể có dung môi Acetonitrile (ACN) trong quá trình sản xuất(hàm lượng ACN dư <
0,41mg/mL). Mục đích của nghiên cứu này là xây dựng và thẩm định phương phápphân tích tồn dư dung môi ACN trong DCPX 18F-FDG. Thiết bị sắc kí khí GC7890B-Agilent chứa đầu dò ion hóangọn lửa (FID), cột HP-INNOWAX 19091N-133, hệ bơm mẫu tự động được sử dụng trong nghiên cứu này.Phương pháp có độ đặc hiệu tốt (thời gian lưu của mẫu và ACN chuẩn tại 3,809 phút). Tính thích hợp của hệthống đạt (độ lệch chuẩn tương đối RSD thời gian lưu 0,019% và độ lệch chuẩn tương đối RSD diện tích pic4,269%). Khoang tuyên tinh xây dưng trong khoảng 0,2 - 0,6mg/mL theo phương trình hồi quy tuyến tính:y = 315,94871x - 1,21442 và hệ số tương quan r = 0,9983. Phương pháp có độ lặp lại (độ lệch chuẩn tươngđối RSD diện tích pic 1,37 %). Độ chính xác trung gian (độ lệch chuẩn RSD giữa 2 kiểm nghiệm viên 2,62%).Giới hạn phát hiện (LOD) là 0,0019mg/mL, giới hạn định lượng (LOQ) là 0,0063mg/mL. Phương pháp nàyđược áp dụng xác định hàm lượng ACN dư trong DCPX 18F-FDG sản xuất tại Trung tâm Chiếu xạ Hà Nội.The validation of the analytical method of residual solvent by gas chromatography (GC) providesobjective evidence that is suitable for its intended purpose. Acetonitrile residual solvent can be found in18F-FDG radiopharmaceuticals (less than 0.41mg/mL). This study aims to research and validate the analyticalmethod for the determination of residual solvents (Acetonitrile) in 18F-FDG radiopharmaceuticals. TheAgilent GC7890B Gas Chromatograph which contains a flame ionization detector (FID), HP-INNOWAX19091N-133 column and autosampler were used in this research. Validation characteristics are based on theGuidelines of the Ministry of Health
The specificity showed good results (retention time of sample andstandard ACN is 3.809 min). The system suitability test showed good results (RSD of retention time is0.019% and RSD of peak area is 4.269%). The linearity was investigated at five concentration levels in arange between 0.2 and 0.6mg/mL concentrations and obtained the linear regression equationy = 315,94871x - 1,21442 with the correlation coefficient r = 0.998. The method has repeatability (RSD ofpeak area is 1.37%). Intermediate precision (RSD between 2 analysts is 2.62%). The limit of detection (LOD)is 0.0019mg/mL, the limit of quantification (LOQ) is 0.0063mg/mL. This method is applied to determine ACNresidual solvent in 18F-FDG radiopharmaceuticals produced at Hanoi Irradiation Center.

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