UV-VIS 분광기기 밸리데이션 및 아미노산유도체 이성질체의 광학분할 연구

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For the increasing demand for the validation of analytical results, one of the important concerns of the analyst is to be assured that the instrumentation is working to qualified conditions. In this study, several validation guidelines of the performance verification of UV-VIS spectrophotometer used in pharmacopoeias of major countries and UV-VIS instrument analytical companies were investigated and compared. And the practically useful validation guidelines of UV-VIS spectrophotometer were proposed. Based on our proposed validation guidelines of UV-VIS spectrophotometer, several UV-VIS spectrophotometers used in drug manufacturing laboratories were validated for their performances.
The liquid chromatographic enantiomer separation of N-fluorenylmethoxycarbonyl (FMOC) protected α-amino acids was performed on nine polysaccharide-derived chiral stationary phases (CSPs). Among all CSPs, in general, the cellulose derived coated CSPs, Chiralcel OD-H and Chiralcel OD showed the greatest performance for resolution of N-FMOC α-amino acids and, therefore, all analytes enantiomers were base-line separated on Chiralcel OD-H or Chiralcel OD. It was observed that the coated type CSPs (Chiralpak AD and Chiralcel OD-H or Chiralcel OD) show generally higher enantioseparation for these analytes than the covalently bonded type CSPs (Chiralpak IA and Chiralpak IB) with the same chiral selector, respectively. Also it was shown that the covalently bonded CSP, Chiralpak IB has the advantage of the use of a broad range of solvents over the coated type CSPs.
Alternative Title
The investigation of instrument validation of UV-VIS spectrophotometer and enantiomer separation of amino acids derivatives
Alternative Author(s)
Kang, Young-ku
조선대학교 대학원
일반대학원 식품의약학과
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Table Of Contents
제 1장 UV-VIS 분광기기 밸리데이션의 연구 = 1
1. 서론 = 2
2. 실험기기 및 방법 = 3
2.1. 실험 기기 = 3
2.2. 실험 방법 = 3
2.2.1. UV-VIS 분광기기 Validation 가이드라인 시행 순서 = 3 Wavelength accuracy 점검 = 4 Wavelength repeatability 점검 = 4 Photometric accuracy 점검 = 5 Photometric repeatability 점검 = 5 Baseline flatness 점검 = 6
3. 실험결과 및 고찰 = 6
3.1. 주요나라 약전에 명시된 UV-VIS분광기기의 validation항목 = 6
3.2. UV-VIS분광기기의 주요기기회사에서 규정한 주요 validation 항목 = 8
3.3. 본 연구에서 제정한 UV-VIS분광기기의 validation항목과 허용 한도 = 9
3.4. 제정한 UV-VIS분광기기의 validation 가이드라인의 적용 = 10
4. 결론 = 11
5. 참고문헌 = 34
제 2장 HPLC를 이용한 아미노산유도체 이성질체의 광학분할 연구 = 36
1. 서론 = 37
2. 실험기기 및 방법 = 38
3. 실험결과 및 고찰 = 38
4. 결론 = 42
5. 참고문헌 = 55
조선대학교 대학원
강영구. (2006). UV-VIS 분광기기 밸리데이션 및 아미노산유도체 이성질체의 광학분할 연구.
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General Graduate School > 4. Theses(Ph.D)
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