Analytical Quality-by-Design approach for HPLC analysis of pharmaceutical mixtures: case studies

Doan Thanh Xuan, Vu Dang Hoang
Cơ quan, tổ chức của tác giả

Các tác giả

  • Doan Thanh Xuan School of Mechanical Engineering, Hanoi University of Science and Technology, 1 Dai Co Viet, Hai Ba Trung, Hanoi, Vietnam
  • Vu Dang Hoang Faculty of Analytical Chemistry & Drug Testing, Hanoi University of Pharmacy, 13-15 Le Thanh Tong, Hoan Kiem Hanoi, Vietnam

DOI:

https://doi.org/10.59882/1859-364X/171

Từ khóa:

AQbD, RP-HPLC, Pharmaceutical mixtures, Robustness, Method development

Tóm tắt

Analytical Quality-by-Design (AQbD) is a methodical approach to method development, which is relatively novel to the analytical scientists. It oversees every phase of the analytical procedure's lifecycle by defining the Analytical Target Profile (ATP), pinpointing critical method parameters (CMPs) or factors, and choosing critical method attributes (CMAs) or responses. Utilizing screening and response-surface experimental designs enables the identification and optimization of significant factors through statistical analysis. It helps establish the design space or Method Operable Design Region (MODR) to ensure robust method performance.

This review discusses the theoretical foundation of AQbD approach for method development and presents its most recent application illustrated in some case studies on HPLC analysis of pharmaceutical mixtures.

Tải xuống

Đã Xuất bản

19-06-2024

Cách trích dẫn

Doan Thanh Xuan, & Vu Dang Hoang. (2024). Analytical Quality-by-Design approach for HPLC analysis of pharmaceutical mixtures: case studies. Tạp Chí Nghiên cứu Dược Và Thông Tin Thuốc, 17, 54–69. https://doi.org/10.59882/1859-364X/171

Số

T. 17 (2024): Tạp chí Nghiên cứu Dược và Thông tin thuốc

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