Related Experiment Video
Updated: Jul 14, 2026
07:34
Large Scale Non-targeted Metabolomic Profiling of Serum by Ultra Performance Liquid Chromatography-Mass Spectrometry UPLC-MS
Published on: March 14, 2013
12.7K
Enhancing Pharmaceutical Analysis with Analytical Quality by Design in UHPLC: A Review of Methodological Innovations
1Department of Quality Assurance, Parul Institute of Pharmacy & Research, Parul University, Vadodara, India.
Critical Reviews in Analytical Chemistry
|June 12, 2025
Summary
Analytical Quality by Design (AQbD) enhances ultrahigh-performance liquid chromatography (UHPLC) for pharmaceutical analysis. This review consolidates methods for robust, efficient, and regulatory-compliant UHPLC development using risk assessment and optimization strategies.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Science
Background:
- Analytical Quality by Design (AQbD) principles are increasingly adopted in pharmaceutical method development.
- Dedicated reviews focusing on AQbD's application in ultrahigh-performance liquid chromatography (UHPLC) are limited.
- Existing literature primarily covers general AQbD or specific pharmaceutical applications, not UHPLC-focused evaluations.
Purpose of the Study:
- To systematically review and consolidate methods and advancements in AQbD-driven UHPLC for pharmaceutical analysis.
- To bridge the gap in dedicated literature concerning AQbD in UHPLC.
- To provide critical insights for regulatory compliance, lifecycle management, and future UHPLC development.
Main Methods:
- Consolidation of reported methods for risk assessment, experimental design, and optimization in UHPLC.
- Identification of critical method parameters (CMPs) using screening designs (e.g., Plackett-Burman design) and risk assessment tools (e.g., Ishikawa diagrams).
- Optimization of UHPLC performance using response surface methodology (RSM) and examination of factors like stationary phases, mobile phase composition, and flow rates.
Main Results:
- Ethylene-bridged hybrid octadecylsilane columns and water-acetonitrile mobile phases with formic acid or ammonium acetate are frequently reported.
- Gradient elution is common for complex separations, with optimized flow rates (0.2-0.5 mL/min) improving efficiency and sustainability.
- Defined Method Operable Design Regions (MODRs) are established through systematic AQbD approaches.
Conclusions:
- AQbD provides a robust framework for developing and optimizing UHPLC methods in the pharmaceutical industry.
- This review offers a comprehensive overview of AQbD strategies applied to UHPLC, aiding researchers and developers.
- The findings support enhanced regulatory compliance, method lifecycle management, and advancements in pharmaceutical analysis.
More Related Videos
11:00Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry UPLC-HRMS
Published on: May 20, 2013
22.4K
06:25Post Column Derivatization Using Reaction Flow High Performance Liquid Chromatography Columns
Published on: April 26, 2016
15.0K
Related Concept Videos
01:21Development of Analytical Methods
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
01:11High-Performance Liquid Chromatography: Introduction
High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
In HPLC, two phases play a critical role in the separation process:
In HPLC, two phases play a critical role in the separation process:
01:05High-Performance Liquid Chromatography: Elution Process
In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
00:57High-Performance Liquid Chromatography: Instrumentation
High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.
01:28Structure-Activity Relationships and Drug Design
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence its...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence its...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...