Chromatographic Methods of Analysis

Proposed by: Cris-Anne A. Juangco III

Objectives

To enumerate types of chromatographic methods used to analyze various drugs

locally and internationally available in market.
To elaborate the principles governing these chromatographic devices and its
application in performing drugs analysis.
To compare the analysis in the reference standards set by the United States
Pharmacopeia and thus, proving the precision and accuracy of the analysis.
To determine different parameters governing the analysis of these
chromatographic devices.

Proposed Outline
1. Introduction
2. Types of Chromatography
2.1. High Performance Liquid Chromatography (HPLC)
2.1.1. Chiral Chromatography
2.1.2. Ion-exchange Chromatography
2.1.3. Ion-pair/Affinity Chromatography
2.1.4. Normal Phase Chromatography
2.1.5. Reversed Phase Chromatography
2.1.6. Size Exclusion Chromatography
2.2. Gas Chromatography (GC)
2.3. Thin-Layer Chromatography
3. Reference Standards
4. Parameters for Validation of High Performance Liquid Chromatographic Methods for
Drug Substance and Drug Product
4.1. Accuracy
4.2. Detection Limit and Quantitation Limit
4.3. Linearity

4.4. Precision
4.4.1. Repeatability
4.4.1.1. Injection Repeatability
4.4.1.2. Analysis Repeatability
4.4.2. Intermediate Precision
4.4.3. Reproducibility
5. Range
6. Recovery
7. Robustness
8. Sample Solution Stability
9. Specificity/Selectivity
10. System Suitability Specifications and Tests
10.1. Capacity factor
10.2. Precision/Injection repeatability
10.3. Relative retention
10.4. Resolution
10.5. Tailing factor
10.6. Theoretical plate number
11. General Points to Consider

Reference:
Center for Drug Evaluation and Research (1994). Validation of Chromatographic
Methods.
Reviewer
Guidance,
CDER:
http://www.fda.gov/downloads/Drugs/Guidances/UCM134409.pdf
United States Pharmacopeia (1990), Vol XXII, p.1225.
Donald Cairns (ed.) (2012). Essentials of Pharmaceutical Chemistry. Pharmaceutical
Press, 4th ed., pp. 199-216, ISBN 978 0 85369 979 8.