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A Comprehensive Guide to HPLC Method Development and Validation
Paperback
Series: Pharmaceutical Industry, Book 3
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Publisher: Independently Published
Published: May 15 2025
Pages: 86
Weight: 0.28
Height: 0.18 Width: 6.00 Depth: 9.00
Language: English
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
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