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High Performance Liquid Chromatography
(HPLC) for Pharmaceutical Analysis 2010
Dr. Shulamit Levin
Private Email
Day 1: Discovery & Research
1-1-Modes of Chromatography: Expansion
Reversed Phase
Ion-Exchange (biomolecules)
Size Exclusion (polymers)
-2-High Throughput Chromatography:
U-HPLC
1-3-Biopharmaceutical Chromatography
Detectors for Drug Discovery (PDA, MS, FLR)
Sample preparation by SPE
LC-MS/MS overview
Day 2: Development: Chemical Synthesis and Formulation
2-1-Quantitative Work using HPLC-Part 1:
Calibration and quantitation
Principles of method validation
2-2-Stability Indicating Methods
Peak Purity and Spectral Matching by PDA and MS
2-3-Separating complex Mixtures
Working with Gradients
Day 3: Manufacturing: QC of API and Dosage Forms
3-1-Quantitative work by HPLC part 2:
System Suitability principles
Integration events
Extraneous peaks in the chromatogram (System Peaks)
3-2-Detection qualification:
Sensitivity, Selectivity, Dynamic range, etc
3-3-Preparative Chromatography:
Scaling up and overloading; Purification of major component; Isolation of minor components
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