Phân tích đồng phân quang học amlodipin bằng HPLC sử dụng cột sắc kí lux cellulose

0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Thị Thu Cúc Lê, Thảo Hạnh Ngân Nguyễn

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Khoa học và Công nghệ - Đại học Nguyễn Tất Thành, 2023

Mô tả vật lý: tr.8

Bộ sưu tập: Báo, Tạp chí

ID: 340484

Thêm vào giỏ Liên kết toàn văn

Amlodipin (AM) gồm hai đồng phân (S)−AM (S) và (R)−AM (R), tuy nhiên, chỉ có (S) được sử dụng. Hiện nay, chưa có chuyên luận riêng cho (S) trong dược điển và phương pháp định lượng, tách (S), (R) tối ưu. Nghiên cứu sử dụng HPLC với các đối tượng nghiên cứu gồm viên nén AM 5 mg
(S)−AM 2,5 mg và 5 mg
chất đối chiếu AM besilat
(S)−AM besilat
các hóa chất, dung môi đạt chuẩn phân tích
các cột tách gồm lux cellulose-(1,2,3,4). Trình tự tiến hành: trước tiên, khảo sát cột, đánh giá khả năng tách. Tiếp theo khảo sát pha động, chọn hệ pha động phù hợp nhất. Cuối cùng, thẩm định phương pháp (theo ICH). Kết quả cho thấy cột lux cellulose-4 tách được hoàn toàn hỗn hợp tại bước sóng 237 nm với hệ acetonitril-ethanol-diethylamin tỉ lệ 90:10:0,1 (v:v:v). Khi thẩm định, phương pháp đạt yêu cầu về tính đặc hiệu, khoảng tuyến tính, độ đúng, độ chính xác, giới hạn phát hiện, giới hạn định lượng với độ phân giải >
2,5, phạm vi định lượng từ (0,1-1) µg/mL, độ lệch chuẩn tương đối <
2 % (n = 6), độ phục hồi (98-102) %. Như vậy, HPLC dùng cột lux cellulose-4 với hệ acetonitril-ethanol-diethylamin (90:10:0,1) phù hợp tách (S) và (R), là một phương pháp mới để định lượng riêng (S), kiểm nghiệm các chế phẩm chứa AM hoặc (S) trên thị trường.Amlodipine (AM) consists of two isomers (S)-AM (S) and (R)-AM (R)
however, only (S) is active. Currently, there is no separate monograph for (S) in the pharmacopoeia and the optimal method of quantification, separation for (S) and (R). Research was carried out using HPLC on research subjects including 5mg AM tablets
2.5mg and 5mg (S)-AM tablets
reference agents AM besilate and (S)-AM besilate
chemicals and solvents up to analytical standards and separation columns include lux cellulose-(1, 2, 3 and 4). Procedure: First, survey the column, evaluate the possibility of separation. Next, investigate the mobile phase, select the most suitable mobile phase system. Finally, validate the method (according to ICH). The results show that the lux cellulose-4 column can completely separate the mixture at 237 nm with the acetonitrile-ethanol-diethylamine system at the ratio of 90:10:0.1 (v:v:v). On validation (according to ICH), the method met requirements for specificity, linearity, precision, accuracy, limit of detection, limit of quantification with resolution >
2.5, range of determination 0.1 to 1.0 µg/mL, relative standard deviation <
2 % (n = 6), recovery (98-102) %. Thus, HPLC using lux cellulose-4 column with acetonitrile-ethanol- diethylamine system (90:10:0,1) proves suitable for separating (S) and (R), thus can be a new method for quantification (S) and testing preparations containing AM or (S) on the market

1. Đọc trực tuyến

1. Đọc trực tuyến

Tạo bộ sưu tập với mã QR