표제지
요약
Abstract
목차
제1장 서론 9
1.1. 개요 9
1.2. 연구배경 및 필요성 10
1.3. 연구의 내용 및 방향 11
제2장 Method development 14
2.1. Selecting of parameter and procedure 14
2.1.1. Reagent & Instrument 14
2.1.2. Procedure 14
2.2. Result for method development 17
2.2.1. Blank solution 17
2.2.2. Analytical column 17
2.2.3. Parameter test 17
2.2.4. Repeatability of standard injection 18
2.3. Determined method parameter 23
2.3.1. GC chromatographic condition 23
제3장 Method Validation 24
3.1. Validation parameter 24
3.1.1. Specificity 24
3.1.2. Accuracy 24
3.1.3. Precision 25
3.1.4. Limit of Detection (LOD) 25
3.1.5. Limit of Quantitation (LOQ) 26
3.1.6. Linearity 26
3.1.7. Robustness 27
3.2. Validation results 28
3.2.1. Summary of result 28
3.2.1. Detail results 33
제4장 결론 53
참고문헌 54
Table 1. Information of residual solvents 12
Table 2. Acceptance criteria of residual solvents 13
Table 3. Peak tailing and resolution for blank chromatogram 20
Table 4. Repeatability for reference standard solution 21
Table 5. Results of resolution 33
Table 6. Results of recovery 36
Table 7. Results of repeatability 37
Table 8. Results of LOD 40
Table 9. Results of LOQ 43
Table 10. Results of linearity 45
Table 11. Results of solution stability 51
Fig. 1. Flow chart for parameter select 16
Fig. 2. Blank chromatogram of development stage 19
Fig. 3. Blank chromatogram 34
Fig. 4. Standard chromatogram 34