Tối ưu quy trình phân tích để định lượng hoạt chất chloramphenicol trong thuốc mỡ bôi da bằng phương pháp sắc kí lỏng hiệu năng cao

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Tác giả: Thanh Nhàn Mai, Thị Thu Thảo Nguyễn

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Khoa học và Công nghệ - Đại học Nguyễn Tất Thành, 2022

Mô tả vật lý: tr.61

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ID: 335814

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An accurate and sensitive method was developed for the qualitative and quantitative analysis of chloramphenicol in ointment using high performance liquid chromatography (HPLC) with UV detection. Experimental results optimized the chromatographic conditions with the mobile phase component being methanol: dikali hydrophosphat solution at (70:30
v/v) at flow rate of 1.0 mL/min which reduced the running time of the samples and the chromatograms obtained met the symmetry coefficient. At the same time, optimizing the processing of samples with a high fat content, using a combination of ultrasound and cooling, % recovery efficiency increased significantly from (65.38 to 100.74) % and relative standard deviation %RSD = 0.67 (<
2) compared to ultrasound – assisted extraction method. Quantitative results of chloramphenicol obtained a linear concentration range of (0.09965-0.2989) mg/mL. The accuracy of the method was determined by the recovery rate in the range of (98.49-101.23) %, corresponding to the concentration of (0,1677-0,2392) mg/mL and the repeatability (in %RSD) of 1.05 %. The analytical procedure met the criteria of specificity, linearity, accuracy, and precision set by the guidance of ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This analytical procedure can be applied in routine quality control of chloramphenicol in ointment.Nghiên cứu hướng đến mục tiêu xây dựng và thẩm định quy trình phân tích định lượng hoạt chất chloramphenicol trong thuốc mỡ bôi da bằng phương pháp sắc kí lỏng hiệu năng cao (HPLC). Kết quả nghiên cứu đã đạt được gồm tối ưu điều kiện sắc kí thành phần pha động methanol : dung dịch dikali hydrogenphosphat theo tỉ lệ (70:30
v/v), giảm thời gian chạy mẫu, sắc kí đồ của peak đáp ứng hệ số đối xứng và dùng kĩ thuật chiết siêu âm kết hợp làm lạnh cho quy trình xử lí mẫu chứa hàm lượng béo cao thông qua hiệu suất thu hồi đạt 100,74 %. Quá trình sắc kí thực hiện trên cột RP-18 (250 mm x 4,6 mm x 5 mm), phát hiện bằng đầu dò UV-VIS ở bước sóng 280 nm. Quá trình rửa giải đẳng dòng với tốc độ dòng 1 mL/min. Kết quả thẩm định theo hướng dẫn của International Conference on Harmonization (ICH) cho thấy quy trình đạt độ đặc hiệu cao, độ tuyến tính, độ lặp lại với %RSD = 0,67, độ đúng với hiệu suất thu hồirong khoảng (98,49-101,23) %. Vì thế, có thể ứng dụng quy trình phân tích này trong việc kiểm soát chất lượng thường quy của chloramphenicol trong dược phẩm thuốc mỡ bôi da.

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