Xây dựng quy trình định lượng một số kháng sinh nhóm Cephalosporin thế hệ 2 bằng phương pháp HPLC với đầu dò PDA dùng kĩ thuật phân tích xanh

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Tác giả: Thị Phương Anh Trần, Quốc Kỳ Trương

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Y Dược học Phạm Ngọc Thạch, 2024

Mô tả vật lý: tr.174

Bộ sưu tập: Metadata

ID: 344815

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Đặt vấn đề: Cefuroxime natri (CFRX) và cefaclor (CFC) là kháng sinh nhóm cephalosporin thế hệ 2, được định lượng bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC) dùng pha động chứa methanol hoặc acetonitril theo Dược điển Việt Nam V. Methanol và acetonitril là dung môi độc theo phân loại của ICH. Do đó phát triển phương pháp phân tích xanh để định lượng CFRX và CFC là vấn đề cần thiết. Đối tượng - Phương pháp: Pha động sử dụng dung môi hữu cơ là ethanol - một dung môi xanh, an toàn cho kiểm nghiệm viên và thân thiện với môi trường. Tiến hành khảo sát các điều kiện sắc ký khác nhau để thu được điều kiện sắc ký tối ưu. Phương pháp được thẩm định theo hướng dẫn của ICH Q2 (R1) và được áp dụng để định lượng một số chế phẩm trên thị trường. Kết quả: Đã xây dựng được quy trình định lượng CFRX và CFC bằng phương pháp HPLC sử dụng cột C18 (5 μm, 150 mm × 4,6 mm) ở 300C, pha động gồm ethanol - amoni acetat 25 mM (9:91, tt/tt), pH pha động là 6,0 cho CFRX và 4,0 cho CFC, nồng độ đệm là 25 mM/l đối với CFRX và 15 mM/l với CFC, tốc độ dòng 1,0 ml/phút, bước sóng phát hiện lần lượt là 273 và 265 nm cho CFRX và CFC. Các phương pháp đạt tất cả các thông số thẩm định và đã được ứng dụng để phân tích một số chế phẩm đang lưu hành trên thị trường có chứa các chất phân tích. Kết luận: Nghiên cứu này đã xây dựng thành công quy trình định lượng hai kháng sinh nhóm cephalosporin thế hệ 2 (cefuroxime natri và cefaclor) bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC) với đầu dò PDA sử dụng kĩ thuật phân tích xanh. Abstract Background: Cefuroxime sodium (CFRX) and cefaclor (CFC) belong to the 2nd generation of cephalosporin antibiotics. According to the 5th Vietnamese Pharmacopoeia, CFRX and CFC are quantified by HPLC using methanol or acetonitrile as organic modifier in the mobile phase. As the ICH categorizes methanol and acetonitrile as toxic solvents, it is critical to develop green analytical methods for the determination of CFRX and CFC. Methods: This research used ethanol as a green organic modifier in the mobile phase, which is safe for the analysts and the environment. Different chromatographic conditions were investigated to obtain the optimal conditions. The developed method was validated on the basis of the ICH Q2 (R1) guideline and applied for quantifying some pharmaceutical products. Results: The appropriate conditions for the determination of CFRX and CFC by HPLC - PDA were conducted on the Sunfire C18 (5 μm, 150 mm × 4.6 mm) column at 300C, the mobile phase consisted of ethanol and ammonium acetate (9:91, v/v ), pH of mobile phase was 6.0 for CFRX and 4.0 for CFC, the buffer’s concentration was 25 mM/l for CFRX and 15 mM/l for CFC, the flow rate was 1,0 ml per minute, the injection volume was 10 μL and the detection wavelength was 273 and 265 nm for CFRX and CFC, respectively. The proposed method achieved all recommended validation criteria and was successfully employed to analyze commercial products containing the studied analytes. Conclusions: An HPLC - PDA method using green analytical chemistry was successfully develop for determination of some β-lactam powders for injection include ertapenem sodium, ampicillin sodium and sulbactam sodium. DOI: 10.59715/pntjmp.2.3.21

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