{"title":"通过设计提高UHPLC分析质量：方法创新综述（2014-2025）。","authors":"Rajendra Kotadiya","doi":"10.1080/10408347.2025.2516607","DOIUrl":null,"url":null,"abstract":"<p><p>The integration of analytical quality by design (AQbD) in ultrahigh-performance liquid chromatography (UHPLC) has enhanced pharmaceutical method development by improving robustness, efficiency, and regulatory compliance. Despite its growing adoption, a dedicated evaluation remains limited. Among 26 review articles on AQbD, none exclusively focuses on UHPLC, while 52 research papers detail its pharmaceutical applications. This review bridges this gap by consolidating reported methods and advancements in risk assessment, experimental design, and optimization strategies for defining the method operable design region (MODR). Screening designs like Plackett-Burman design (PBD) and risk assessment tools like Ishikawa diagrams identify critical method parameters (CMPs), while response surface methodology (RSM)-based models optimize performance. The impact of stationary phases, mobile phase composition, and flow rate adjustments is examined, emphasizing ethylene-bridged hybrid octadecylsilane columns and mobile phase trends favoring water-acetonitrile (CAN) combinations with formic acid (FA) or ammonium acetate. Gradient elution is frequently applied for complex separations, with optimized flow rates (0.2-0.5 mL/min) enhancing efficiency and sustainability. Unlike previous reviews, this study systematically evaluates AQbD-driven UHPLC, offering critical insights for regulatory compliance, lifecycle management, and future pharmaceutical analysis advancements.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-21"},"PeriodicalIF":5.2000,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Enhancing Pharmaceutical Analysis with Analytical Quality by Design in UHPLC: A Review of Methodological Innovations (2014-2025).\",\"authors\":\"Rajendra Kotadiya\",\"doi\":\"10.1080/10408347.2025.2516607\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The integration of analytical quality by design (AQbD) in ultrahigh-performance liquid chromatography (UHPLC) has enhanced pharmaceutical method development by improving robustness, efficiency, and regulatory compliance. Despite its growing adoption, a dedicated evaluation remains limited. Among 26 review articles on AQbD, none exclusively focuses on UHPLC, while 52 research papers detail its pharmaceutical applications. This review bridges this gap by consolidating reported methods and advancements in risk assessment, experimental design, and optimization strategies for defining the method operable design region (MODR). Screening designs like Plackett-Burman design (PBD) and risk assessment tools like Ishikawa diagrams identify critical method parameters (CMPs), while response surface methodology (RSM)-based models optimize performance. The impact of stationary phases, mobile phase composition, and flow rate adjustments is examined, emphasizing ethylene-bridged hybrid octadecylsilane columns and mobile phase trends favoring water-acetonitrile (CAN) combinations with formic acid (FA) or ammonium acetate. Gradient elution is frequently applied for complex separations, with optimized flow rates (0.2-0.5 mL/min) enhancing efficiency and sustainability. Unlike previous reviews, this study systematically evaluates AQbD-driven UHPLC, offering critical insights for regulatory compliance, lifecycle management, and future pharmaceutical analysis advancements.</p>\",\"PeriodicalId\":10744,\"journal\":{\"name\":\"Critical reviews in analytical chemistry\",\"volume\":\" \",\"pages\":\"1-21\"},\"PeriodicalIF\":5.2000,\"publicationDate\":\"2025-06-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Critical reviews in analytical chemistry\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://doi.org/10.1080/10408347.2025.2516607\",\"RegionNum\":2,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Critical reviews in analytical chemistry","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1080/10408347.2025.2516607","RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
Enhancing Pharmaceutical Analysis with Analytical Quality by Design in UHPLC: A Review of Methodological Innovations (2014-2025).
The integration of analytical quality by design (AQbD) in ultrahigh-performance liquid chromatography (UHPLC) has enhanced pharmaceutical method development by improving robustness, efficiency, and regulatory compliance. Despite its growing adoption, a dedicated evaluation remains limited. Among 26 review articles on AQbD, none exclusively focuses on UHPLC, while 52 research papers detail its pharmaceutical applications. This review bridges this gap by consolidating reported methods and advancements in risk assessment, experimental design, and optimization strategies for defining the method operable design region (MODR). Screening designs like Plackett-Burman design (PBD) and risk assessment tools like Ishikawa diagrams identify critical method parameters (CMPs), while response surface methodology (RSM)-based models optimize performance. The impact of stationary phases, mobile phase composition, and flow rate adjustments is examined, emphasizing ethylene-bridged hybrid octadecylsilane columns and mobile phase trends favoring water-acetonitrile (CAN) combinations with formic acid (FA) or ammonium acetate. Gradient elution is frequently applied for complex separations, with optimized flow rates (0.2-0.5 mL/min) enhancing efficiency and sustainability. Unlike previous reviews, this study systematically evaluates AQbD-driven UHPLC, offering critical insights for regulatory compliance, lifecycle management, and future pharmaceutical analysis advancements.
期刊介绍：
Critical Reviews in Analytical Chemistry continues to be a dependable resource for both the expert and the student by providing in-depth, scholarly, insightful reviews of important topics within the discipline of analytical chemistry and related measurement sciences. The journal exclusively publishes review articles that illuminate the underlying science, that evaluate the field''s status by putting recent developments into proper perspective and context, and that speculate on possible future developments. A limited number of articles are of a "tutorial" format written by experts for scientists seeking introduction or clarification in a new area.
This journal serves as a forum for linking various underlying components in broad and interdisciplinary means, while maintaining balance between applied and fundamental research. Topics we are interested in receiving reviews on are the following:
· chemical analysis;
· instrumentation;
· chemometrics;
· analytical biochemistry;
· medicinal analysis;
· forensics;
· environmental sciences;
· applied physics;
· and material science.
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