Xây dựng phương pháp phân tích định lượng hàm lượng cefuroxime trong bột pha hỗn dịch zinat 125mg bằng phương pháp HPLC

0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Tân Huỳnh

Ngôn ngữ: vie

Ký hiệu phân loại: 543.4 Electrochemical analysis

Thông tin xuất bản: Tạp chí khoa học và công nghệ - Đại học Nguyễn Tất Thành, 2018

Mô tả vật lý: 74-80

Bộ sưu tập: Metadata

ID: 492378

Thêm vào giỏ

Bài báo trình bày quá trình xây dựng và thẩm định phương pháp HPLC với đầu dò PDA định lượng cefuroxime trong bột pha hỗn dịch zinat 125mg. Phương pháp HPLC với đầu dò PDA, cột C18 pha đảo, pha động gồm methanol - dung dịch amoni dihydrogen phosphat 0,2M theo tỉ lệ (38:62
v:v) tốc dộ dòng 1ml/phút, bước sóng phát hiện 278nm. Khảo sát tính tương thích của hệ thống sắc ký cho thấy hệ số phân giải giữa Cefuroxim axetil diasteroisomer B và Cefuroxim axetil diasteroisomer A trong dung dịch chuẩn ≥1,5 (3,734). Hệ số phân giải giữa Cefuroxim axetil diasteroisomer B và Cefuroxim axetil delta - 3 isomer≥1,5 (2,530). Số đĩa lý thuyết đối với Cefuroxim axetil diasteroisomer A>
3000 (9532,2), %RSD các lần tiêm lặp lại không quá 2,0%. Cefuroxim axetil diasteroisomer B: 0,95. Cefuroxim axetil diasteroisomer A: 1,05. Tính đặc hiệu: Độ lệch thời gian lưu của mẫu chuẩn và mẫu thử: 0,066%. Độ lặp lại: hàm lượng mẫu trong khoảng 90% ÷ 115%, với %RSD = 0,11<
2%. Độ đúng của phương pháp trong khoảng 98,97% ÷ 100,51% . Theo tiêu chuẩn của USP34 thì độ ổn định của thuốc bột cefuroxime, tính tương thích của hệ thống sắc ký, tính tuyến tính, tính đặc hiệu, độ lặp lại, độ dung đạt yêu cầu phân tích.This paper presents the process of developing and validating the HPLC method with PDA detector for the determination of cefuroxime in zinnat suspension 125mg. Under the conditions of reverse phase C18 column, mobile phase consisting of methanol - 0.2M ammonium dihydrogen phosphate solution (38:62
v/v respectively), and flow rate 1ml.min-1, the detector wavelength is 278nm. Examination of chromatographic system compatibility showed the resolution coefficient between Cefuroxime Acetyl Diasteroisomer B and Cefuroxime Acetyl Diasteroisomer A in standard solution is higher than or equal to 1.5 (3.734). The resolution factor between Cefuroxime axetil diasteroisomer B and Cefuroxime axetil delta-3 isomer is higher than or equal to 1.5 (2.530). The number of theoretical plates for Cefuroxime axetil diasteroisomer A>
3000 (9532.2) with % RSD repeated repeat doses not more than 2.0%. Cefuroxime axetil diastereoisomer B: 0.95. Cefuroxime axetil diasteroisomer A: 1.05. Specificity: Time deviation of sample and sample: 0.066%. Repeatability: Sample content is in the range of 90% to 115%, with % RSD = 0.11 <
2%. The correctness of the method is in the range of 98.97% to 100.51%. In accordance with USP34 standards, the stability of cefuroxime powder, the compatibility of the chromatography system, linearity, specificity, repetition, and the correctness meet the desired level of analysis.

1. Đọc trực tuyến

1. Đọc trực tuyến

Tạo bộ sưu tập với mã QR