Xây dựng quy trình định lượng thuốc tiêm nhóm Beta - Lactam (Ertapenem, Ampicillin và Sulbactam) 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

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

Mô tả vật lý: tr.164

Bộ sưu tập: Metadata

ID: 344331

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Đặt vấn đề: Mục tiêu chính của hóa học phân tích xanh (GAC) là phát triển các phương pháp phân tích thân thiện với môi trường và sức khỏe bằng cách thay thế hoặc không sử dụng các dung môi độc trong quy trình phân tích. Trong nghiên cứu này, phương pháp phân tích xanh đã được áp dụng để định lượng thuốc bột pha tiêm nhóm β-lactam gồm ertapenem natri (ETP), ampicillin natri (APC) và sulbactam natri (SUL) bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC) với đầu dò dãy diod quang (PDA). Đối tượng - Phương pháp: Ethanol được dùng làm dung môi xanh thay thế cho các dung môi độc thường được sử dụng trong phân tích sắc ký, chẳng hạn như methanol và acetonitril. Các điều kiện sắc ký khác nhau đã được khảo sát để đạt được các điều kiện 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 ETP, APC và SUL 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 ETP và 5,0 cho APC và SUL, tốc độ dòng 1,0 ml/phút, bước sóng phát hiện là 294 nm cho ETP và 210 nm cho APC và SUL. Các phương pháp đạt tất cả các thông số thẩm định và đã được ứng dụng để phân tích các chế phẩm có chứa ETP hoặc dạng kết hợp hai hoạt chất APC và SUL trên thị trường. Kết luận: Nghiên cứu này đã xây dựng thành công quy trình định lượng thuốc bột pha tiêm tiêm nhóm β-lactam gồm ertapenem natri, ampicillin natri và sulbactam natri bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC) với đầu dò PDA sử dụng kĩ thuật phân tích xanh.Abstract Background: Green analytical chemistry (GAC) primary goal is to develop environmental and health - friendly analytical methods by eradicating or replacing hazardous substances from analytical procedures. In this research, the application of GAC to quantify some β-lactam powders for injection include ertapenem sodium (ETP), ampicillin sodium (APC) and sulbactam sodium (SUL) by high - performance liquid chromatography (HPLC) using photodiode arrays (PDA) detector was developed. Methods: Ethanol was used as a green alternative to commonly used but hazardous solvents in chromatographic analysis, such as methanol and acetonitrile. Several chromatographic conditions were investigated to accomplish 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 chromatographic conditions appropriate for the determination of ETP, APC and SUL have been developed by HPLC method using the Sunfire C18 (5 μm, 150 mm × 4.6 mm) column set at 300C, the mobile phase consisted of ethanol and ammonium acetate 25 mM (9:91, v/v ), pH of mobile phase was 6.0 for ETP and 4.0 for APC and SUL, the flow rate was 1,0 ml per minute, the injection volume was 10 μL and the detection wavelength was 294 for ETP and 210 nm for APC and SUL. The proposed method achieved all recommended validation criteria and was successfully employed to analyze commercial products containing ETP or combinations of APC and SUL. Conclusions: An HPLC-PDA method using green analytical chemistry was successfully developed to determine some β-lactam powders for injection, including ertapenem sodium, ampicillin sodium, and sulbactam sodium. DOI: 10.59715/pntjmp.2.3.20

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