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A Comprehensive Guide to HPLC Method Development and Validation (Pharmaceutical Industry Book) by Mirela Gorjanu
English | May 14, 2025 | ISBN: N/A | ASIN: B0F8NLDGWM | 71 pages | EPUB | 0.22 Mb
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 developmentSelection of stationary phases, buffers, pH, and organic modifiersGradient vs. isocratic separation strategiesSample preparation, filtration, and matrix effectsRegulatory validation (ICH Q2(R2), USP <1225>) with real examplesTroubleshooting guide: peak tailing, split peaks, ghost peaks, retention driftSpecialized methods: stability-indicating, chiral separations, LC-MS compatibilityWith real-world case studies and diagrams, this guide demystifies complex techniques and empowers both novice and experienced chromatographers.
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