Xây dựng và thẩm định quy trình định lượng viên nén bao phim chứa hoạt chất Cefditoren pivoxil bằng phương pháp HPLC

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Tác giả: Đăng Thoại Nguyễn, Thị Xuân Thùy Nguyễn, 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, 2023

Mô tả vật lý: tr.48

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ID: 339181

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- Đặt vấn đề: Cefditoren pivoxil là kháng sinh thuộc nhóm cephalosporin thế hệ 3, được bào chế dạng viên nén bao phim. Phương pháp định lượng viên nén bao phim cefditoren pivoxil chưa được quy định trong Dược điển Việt Nam V. Do đó xây dựng quy trình định lượng viên nén bao phim cefditoren pivoxil là một vấn đề cần thiết.- Đối tượng - Phương pháp: Viên nén bao phim chứa hoạt chất cefditoren pivoxil được định lượng bằng kỹ thuật sắc ký lỏng hiệu năng cao pha đảo với đầu dò PDA. Quy trình được tối ưu hóa bằng phần mềm Design Expert 12, thẩm định theo hướng dẫn của ICH và Sổ tay đăng ký thuốc của Bộ Y tế và áp dụng để định lượng mẫu chế phẩm trên thị trường.- Kết quả: Đã xây dựng quy trình định lượng cefditoren pivoxil trong viên nén bao phim bằng phương pháp HPLC. Sau khi được tối ưu hóa bằng phần mềm Design Expert, điều kiện sắc ký gồm cột Sunfire C18 (150 x 4,6 mm
5µm), pha động gồm methanol: nước (62:38, tt/tt), bước sóng phát hiện 240nm, tốc độ dòng 1,0ml/phút và nhiệt độ cột 300 C. Kết quả thẩm định cho thấy quy trình có tính chọn lọc cao, khoảng tuyến tính từ 10 - 400µg/ml, tỷ lệ phục hồi nằm trong khoảng 98 - 102% và độ chính xác có RSD <
2%. Đã áp dụng quy trình vào việc định lượng viên nén bao phim chứa cefditoren pivoxil trên thị trường. Kết quả hàm lượng cefditoren pivoxil trong khoảng 90 - 110%.- Kết luận: Đề tài này đã xây dựng thành công quy trình định lượng viên nén bao phim cefditoren pivoxil bằng phương pháp HPLC. Quy trình này đã được thẩm định và áp dụng để phân tích mẫu chế phẩm trên thị trường Việt Nam.Abstract- Background: Cefditoren pivoxil is a 3rd generation of the cephalosporin, available commercially in film - coated tablet formulations. Method for the determination of cefditoren pivoxil is not yet available in the 5th Vietnamese Pharmacopoeia. Therefore, it is necessary to develop and validate a method for the quantification of film - coated tablets containing cefditoren pivoxil.- Methods: Cefditoren pivoxil in film - coated tablets was determined by high - performance liquid chromatography (HPLC) with photodiode array (PDA) detector. The method was optimized using Design Expert 12 program, validated based on ICH guideline, and applied to commercial formulations.- Results: The optimal chromatographic conditions for the quantification of cefditoren pivoxil were found out by Design Expert 12 program: a Sunfire C18 (150 × 4.6 mm
5µm), mobile phase consisting of methanol and water (62:38, v/v), flow rate of 1.0ml/min, detection wavelength of 240 nm and column temperature of 300 C. The method was shown high selectivity, a wide linearity range from 10 - 400µg/ml. Intra-day standard deviation was below 2% and the recovery range was 98 - 102%. The method was applied to commercial formulations, and the assay results were within 90 - 110%.- Conclusions: The method for the quantification of cefditoren pivoxil in film - coated tablet formulations by HPLC was successfully developed. This method was validated and applied to analyze commercial products in Vietnam market. DOI: 10.59715/pntjmp.2.1.6

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