Analytical quality by design oriented development of the UPLC method for analysing multiple pharmaceutical process intermediates: A case study of Compound Danshen Dripping Pills-Reference-Cited by-同舟云学术

Analytical quality by design oriented development of the UPLC method for analysing multiple pharmaceutical process intermediates: A case study of Compound Danshen Dripping Pills

Published:2023-04 Issue: Volume:187 Page:108438
ISSN:0026-265X
Container-title:Microchemical Journal
language:en
Short-container-title:Microchemical Journal

Author:

Tai Yanni,Ren Dandan,Zhao Wanshun,Qu Haibin,Xiong Haoshu,Gong Xingchu

Publisher

Elsevier BV

Subject

Spectroscopy,Analytical Chemistry

Reference42 articles.

1. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Q14 (R1): Analytical Procedure Development.

2. Development of a fast high performance liquid chromatographic screening system for eight antidiabetic drugs by an improved methodology of in-silico robustness simulation;Mokhtar;J. Chromatogr. A,2015

3. Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation;Monks;J. Chromatogr. A,2012

4. Guidance for robustness/ruggedness tests in method validation;Vander Heyden;J. Pharm. Biomed. Anal.,2001

5. Understanding pharmaceutical quality by design;Yu;AAPS J.,2014

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