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[资源] 色谱方法指导原则——FDA药品评价中心（CDER）

色谱方法指导原则——FDA药品评价中心（CDER）
TABLE OF CONTENTS
I. INTRODUCTION ............................................... 1
II. TYPES OF CHROMATOGRAPHY ................................. 2
A. High Performance Liquid Chromatography (HPLC) ............... 2
1. Chiral Chromatography ............................... 2
2. Ion-exchange Chromatography ......................... 3
3. Ion-pair/Affinity Chromatography ........................ 3
4. Normal Phase Chromatography ......................... 3
5. Reversed Phase Chromatography ....................... 3
6. Size Exclusion Chromatography ........................ 4
B. Gas Chromatography (GC) .................................. 4
C. Thin-Layer Chromatography (TLC) ............................ 5
III. REFERENCE STANDARDS ...................................... 5
IV. PARAMETERS FOR VALIDATION OF HPL CHROMATOGRAPHIC
METHODS FOR DRUG SUBSTANCE AND DRUG PRODUCT .......... 7
A. Accuracy ................................................ 8
B. Detection Limit and Quantitation Limit ......................... 8
C. Linearity ................................................  11
D. Precision ................................................  13
1. Repeatability ........................................  13
a. Injection Repeatability ...........................  13
b. Analysis Repeatability ...........................  15
2. Intermediate Precision ................................  15
3. Reproducibility ......................................  16
E. Range ..................................................  16
F. Recovery ................................................  16
G. Robustness ..............................................  16
H. Sample Solution Stability ...................................  17
I. Specificity/selectivity .......................................  17
J. System Suitability Specifications and Tests .....................  21
1. Capacity factor ......................................  22
2. Precision/Injection repeatability .........................  22
3. Relative retention ....................................  22
4. Resolution .........................................  22
5. Tailing factor ........................................  23
6. Theoretical plate number ..............................  26
K. General Points to Consider ..................................  28
V. COMMENTS AND CONCLUSIONS ................................  29
VI. ACKNOWLEDGEMENTS ........................................  29
VII. REFERENCES ................................................  29

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