High-Performance Liquid Chromatography (HPLC) is the analytical backbone of pharmaceutical, chemical, and environmental laboratories.
A Comprehensive Guide to HPLC Method Development and Validation offers a detailed, application-focused guide to HPLC method development and validation, helping scientists move from raw data to robust, regulatory-compliant results.
Whether you're troubleshooting existing methods or building one from scratch, this book delivers step-by-step guidance covering every aspect-from column selection and mobile phase optimization to forced degradation, peak purity, and system suitability criteria.
Key topics include:
- Analytical target profile (ATP) and Quality by Design (QbD) in method development
- Selection of stationary phases, buffers, pH, and organic modifiers
- Gradient vs. isocratic separation strategies
- Sample preparation, filtration, and matrix effects
- Regulatory validation (ICH Q2(R2), USP ) with real examples
- Troubleshooting guide: peak tailing, split peaks, ghost peaks, retention drift
- Specialized methods: stability-indicating, chiral separations, LC-MS compatibility
With real-world case studies and diagrams, this guide demystifies complex techniques and empowers both novice and experienced chromatographers.
