Developing an improved UHPLC method for impurity profile analysis of ceftriaxone using analytical quality by design-Reference-Cited by-同舟云学术

Developing an improved UHPLC method for impurity profile analysis of ceftriaxone using analytical quality by design

Published:2023 Issue:5 Volume:15 Page:639-647
ISSN:1759-9660
Container-title:Analytical Methods
language:en
Short-container-title:Anal. Methods

Author:

Xiao Chaoqiang¹²³^ORCID,Zhang Xia⁴,Wang Wei²,Yang Xiuyun²,Sun Ying²,Zhang Weifeng³,He Shuwang³,Yang Jie³,Lv Zhihua¹^ORCID,Hu Changqin⁴

Affiliation:

1. Key Laboratory of Marine Drugs, Chinese Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao, 266003, China

2. Dyne High-tech Pediatric Pharmaceutical R&D Institute, Beijing, 100176, China

3. Shandong Dyne Marine Organism Pharmaceutical Co., Ltd, Weihai, 264300, China

4. Key Laboratory for Quality Research and Evaluation of Chemical Drugs, National Institutes for Food and Drug Control, Beijing, 102629, China

Abstract

A new UHPLC method was developed based on the quality-by-design principle which could serve as a reference for developing future versions of the pharmacopoeia standards.

Funder

Natural Science Foundation of Shandong Province

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2023/AY/D2AY02016E

Reference26 articles.

1. Development of a method of analysis for profiling of the impurities in phenoxymethylpenicillin potassium based on the analytical quality by design concept combined with the degradation mechanism of penicillins

2. Critical review of reports on impurity and degradation product profiling in the last decade

3. Quality by Design: Concept to Applications

4. Development of Quality-By-Design Analytical Methods

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