Định lượng đồng thời các hợp chất axit ascorbic, acetaminophen, phenylephrin HCl, guaifenesin, dextromethorphan HBr trong thuốc viên bằng phương pháp sắc ký lỏng hiệu năng cao=Simultaneous quantification of the compounds ascorbic acid, acetaminophen, phenylephrine HCl, guaifenesin, and dextromethorphan HBr in tablets using high-performance liquid chromatography

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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, 2024

Mô tả vật lý: tr.17

Bộ sưu tập: Metadata

ID: 481645

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Nghiên cứu thực hiện với hai mục tiêu: xây dựng và thẩm định quy trình định lượng đồng thời axit ascorbic, acetaminophen, phenylephrin HCl, guaifenesin, dextromethorphan HBr ở dạng thuốc viên bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC), và ứng dụng quy trình đã thẩm định để định lượng một số mẫu trên thị trường có chứa các hợp chất trên. Việc phân tách sắc ký được thực hiện trên cột pha đảo C18 (250 mm × 4,6 mm, 5 μm), dùng kiểu rửa giải gradient với pha động A (đệm photphat pH = 3,0) và pha động B (acetonitril). Kết quả nghiên cứu thu được khoảng nồng độ tuyến tính lần lượt axit ascorbic, phenylephrin HCl, acetaminophen, guaifenesin và dextromethorphan HBr là (8-56, 16-104, 40-240, 16-80 và 24-146) mg∙mL−1. Độ đúng phương pháp được xác định bằng tỷ lệ phục hồi trong khoảng (98,80-101,27) %. Độ lặp lại có phần trăm độ lệch chuẩn tương đối (% RSD) là 0,64 % (<
2,0 %). Phương pháp đề xuất có thể áp dụng để định lượng sáu loại thuốc viên đang lưu hành trên thị trường, và cả sáu mẫu thuốc đều đạt hàm lượng theo quy định Dược điển Việt Nam V.The present study was conducted with two objectives: (1) construction and validation of a simultaneous quantitative process for ascorbic acid, acetaminophen, phenylephrine HCl, guaifenesin, and dextromethorphan HBr in tablet form using the HPLC method, and (2) application to quantify some commercial products containing these compounds. The chromatographic separation of these five pharmaceutical compounds was performed on a C18 reverse-phase column (250 mm × 4.6 mm, 5 μm), using a gradient elution program with mobile phases A (phosphate buffer pH = 3.0) and B (acetonitrile). The research results obtained linear concentration ranges for ascorbic acid, phenylephrine HCl, acetaminophen, guaifenesin, and dextromethorphan HBr as (8-56, 16-104, 40-240, 16-80, and 24-146) µg∙mL−1, respectively. The accuracy of the method was determined by recovery rates in the range of (98.80-101.27) %. The repeatability with the relative standard deviation (% RSD) was 0.64 %, which is less than 2.0 %. The proposed method can effectively quantify six types of commercial tablets, all of which meet the content requirements of the Vietnamese Pharmacopoeia V.

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