Bài viết trình bày việc xây dựng bộ phổ để nhận dạng và phương pháp xác định độ tinh khiết sắc ký HPLC/DAD của nguyên liệu chất chuẩn tạp A mebendazol. Phương pháp nghiên cứu: Đo phổ NMR, HR-MS, IR, UV, nhiệt độ nóng chảy khẳng định cấu trúc và xây dựng phương pháp xác định độ tinh khiết tạp A bằng HPLC/DAD sử dụng kỹ thuật pha loãng dung dịch thử. | Nghiên cứu Dược amp Thông tin thuốc 2023 Tập 14 Số 2 trang 19-26 BÀI NGHIÊN CỨU Identification and Chromatographic purity determination of mebendazole s impurity A reference standard Nguyen Lam Hong1 Nguyen Trung Nghia1 Ngo Duc Huy2 Ngo Minh Thuy1 Nguyen Thị Thu Phuong3 Nguyen Van Hai2 1 Faculty of Analytical Chemistry and Drug Quality Control Hanoi University of Pharmacy 13-15 Le Thanh Tong Hoan Kiem Hanoi Vietnam 2 Faculty of Pharmaceutical Chemistry and Technology Hanoi University of Pharmacy 13-15 Le Thanh Tong Hoan Kiem Hanoi Vietnam 3Pasteur Institute in Ho Chi Minh City 167 Pasteur Vo Thi Sau Ward District 3 Ho Chi Minh City Corresponding author Nguyen Lam Hong email hongnl@ ABSTRACT Background Mebendazole s impurity A standard methyl 5-benzoyl-1H-benzimidazol-2- yl carbamate is speci ed in pharmacopoeia monographs for mebendazole and mebendazole tablets . USP 43 BP 2020 and Vietnamese Pharmacopoeia V and set at not more than . It is also a component of the standard mixture for mebendazole system suitability testing. Aim This study was carried out to establish spectral dataset for identi cation of mebendazole s impurity A standard and HPLC DAD chromatographic method for its content determination. Method Mebendazole s impurity A standard was structurally identi ed by NMR HR-MS IR UV spectroscopy melting point. This standard s content was HPLC DAD determined using the dilution method. Results A dataset including HR-MS 1D-NMR IR UV spectra and melting point was successfully established for identi cation of mebendazole s impurity A standard. An HPLC method was also developed to quantify this standard. According to the validation data the method was speci c linear in the range from to 10 ppm precise RSD . The content of mebendazole s impurity A standard was chromatographically determined to be . Conclusions Mebendazole s impurity A standard was structurally identi ed by HR-MS 1D- NMR IR UV spectral dataset. Using the .
