Tối ưu hóa qui trình phân tích để định lượng cefaclor trong viên nang cứng 250 mg bằng phương pháp sắc kí lỏng hiệu năng cao

0 Người đánh giá. Xếp hạng trung bình 0

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, 2023

Mô tả vật lý: tr.64

Bộ sưu tập: Metadata

ID: 347417

Thêm vào giỏ Liên kết toàn văn

Các chất bảo quản methylparaben và propylparaben được dùng chủ yếu trong dược phẩm và mỹ phẩm. Tuy nhiên, việc kiểm soát các chất bảo quản là điều cần thiết do các chất bảo quản này cần được sử dụng trong nồng độ cho phép để đảm bảo sự an toàn của người tiêu dùng. Nghiên cứu nhằm mục đích đưa ra qui trình định lượng đồng thời methylparaben và propylparaben trong kem bôi da bằng phương pháp sắc kí lỏng hiệu năng cao. Qui trình gồm các bước hoà tan mẫu trong ethanol : H2O (70 : 30, v/v) và định lượng bằng phương pháp sắc kí lỏng hiệu năng cao, sử dụng cột RP–18 (250 mm x 4,6 mm x 5 mm), đầu dò photo diode array (PDA) với bước sóng phát hiện 256 nm, pha động methanol : đệm kali dihydrophosphat (65 : 35, v/v). Phương pháp phân tích có độ đặc hiệu, độ tuyến tính, độ đúng và độ lặp lại đạt yêu cầu theo hướng dẫn nội dung và phương pháp của Hội nghị Hài hòa Quốc tế (International Conference on Harmonization – ICH). Phương pháp này phù hợp để phân tích các loại kem bôi da có chứa thành phần chất bảo quản methylparaben và propylparaben.The aim of study was to develop an accurate and sensitive method for quantitative determination of cefaclor 250 mg in hard capsules using ion-pair. Cefaclor is a zwitterion and the degree of ionization of cefaclor affects the retention of compound in the reversed phase chromatographic column by investigating the concentration of buffer solution at pH 2.5, pH 4.5 and pH 7.5. The experimental results optimized mobile phase composition at pH 2.5, with a flow rate 1.5 mL.min−1 and samples were prepared with the volume of mobile phase was injected at 10 μL, the symmetrical shape chromatography was symmetrical with tailing resolution at 0.988. Chromatography parameters were stainless steel RP–18 column (250 mm × 4.6 mm i.d., 5 μm particle size), at 40 ℃. The determinations were performed using PDA detector at 265 nm. The method is validated for the specificity, linearity, and was applied successfully to determine the content of cefaclor in 250 mg hard capsules with recovery of 100.05 % and a relative standard deviation smaller than 2.0% (%RSD = 0.40). This proposed method is applicable for the determination of three pharmaceutical preparations of cefaclor in hard capsule drugs in the market. The results showed that all samples met the cefaclor content as prescribed by the Vietnamese Pharmacopoeia V.

1. Đọc trực tuyến

1. Đọc trực tuyến

Tạo bộ sưu tập với mã QR