화학적 시험방법의 유효성 확인(Method Validation)

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"화학적 시험방법의 유효성 확인(Method Validation)"에 대한 내용입니다.

목차

Ⅰ. 서 론 ··················································································································1
1. 배경 ·················································································································1
2. 목적 ·················································································································1

Ⅱ. 유효성 수행인자 ·····························································································1
1. 선택성 (Selectivity) ·················································································1
2. 직선성 (Linearity) ·····················································································1
3. 감 도 (Sensitivity) ·················································································2
4. 정확도 (Accuracy) ·······················································································3
4.1 정밀도 (Precision) ···············································································3
4.2 진 도 (Trueness) ·················································································3
5. 검출한계/정량한계/분석방법 검출한계 ·················································4
5.1 검출한계 (LOD)와 정량한계 (LOQ) ···················································4
5.2 분석방법 검출한계 (MDL) ···································································5
6. 범 위 (Range) ·····························································································6
7. 둔감도 (Ruggedness) ···················································································6
8. 측정불확도 (Measurement Uncertainty) ·················································6

본문내용

Ⅰ. 서 론
1. 배 경
화학적 시험방법의 유효성 확인 (Method Validation)을 위한 KOLAS 지침에 의하면 시험기관에서 시험방법을 적용하기에 앞서 시험 목적에 적합한지의 여부를 먼저 검증하여, 고객이 이 방법을 통해 얻은 결과를 확신을 가지고 활용할 수 있도록 함.

2. 목 적
KS K ISO 14184-1:1998(2018.11.20. 개정)에 따른 폼알데하이드 측정방법에 대한 유효성을 확인함.

Ⅱ. 유효성 수행인자 (Validation parameter)
시험방법의 유효성 확인은 분석물질을 정량 분석하는 데에 사용되는 특정 방법이 믿을만하고 재현성이 있다는 것을 증명하는 모든 과정을 포함한다. 이러한 유효성 확인을 위한 기본적인 요소 (Parameters) 로는 다음과 같은 것들이 있음.

1. 선택성 (Selectivity)
시험방법의 선택성은 간섭물질이 존재할 때의 측정의 정확성을 뜻한다. 해당 시험표준에 의해 UV/Vis spectrophotometer로 폼알데하이드의 측정파장을 확인하였을 때 다른 방해물질에 의한 간섭이 없음을
확인함.
물질명 선택 파장(nm)
폼알데하이드 412

2. 직선성 (Linearity)
장비의 응답값 (Instrumental responds)과 분석물질의 농도와의 관계로 나타낸다. 장비의 응답값 (y)과 농도 (x)의 관계식을 직선 모델인 y=ax+b로 만들 때 고전적인 최소 제곱 회귀법이 사용됨. 직선성은 6개의 검량 표준 용액을 사용하여 검량선을 구한 후 상관계수, y-절편, 검량선의 기울기 및 잔차제곱의 합을 구하여 검량선 농도범위 안에서 분석물질의 농도에 상응하는 측정결과를 얻을 수 있는가를 확인함.
UV/Vis spectrophotometer로 측정한 폼알데하이드의 검량선은 각각 0.145 2 mg/L, 0.290 4 mg/L, 0.726 0 mg/L, 1.452 0 mg/L, 2.178 0mg/L, 2.904 0 mg/L, 4.356 0 mg/L, 5.808 0 mg/L 농도로 제조한 표준용액 대비 응답값으로부터 얻었으며, 0.995이상의 결정계수 (r2) 를 나타냄.

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