The validationwasperformedaccording

The validationwasperformedaccordingtoUS-FDAguidance
for industryonbioanalyticalmethodvalidation [33]. Thevalida-
tion studieswerecarriedoutusingpooledplasmasamplepre-
analyzedforvitaminKcontentbeforespikingofstandardvitamin
K homologues.Threedaysofcalibrationcurveswitheightre-
plicates ofplasmasamplesspikedwithamixtureofstandardvi-
tamin Khomologues(MK-4,PKandMK-7)overconcentration
rangeof0.3-100ngmL
1 and I.S.(5ngmL
1) wereperformedto
assess linearityofthedevelopedHPLC-FLmethod.Thelimitof
quantitation(LOQ)wasestablishedasthelowestconcentrationof
the calibrationcurvethatcanbequantified withacceptableac-
curacy andprecision.Moreover,theanalyteresponseatthiscon-
centration mustbeatleast10timesthebaselinenoise(S/N¼10).
The limitofdetection(LOD)wasestablishedasthelowestcon-
centration ofananalytethatcanbedetectedbutnotnecessarily
quantified andtheanalyteresponseatthisconcentrationmustbe
at least3timesthebaselinenoise(S/N¼3).
Toevaluateintra-dayandinter-dayprecisionandaccuracy

ผลลัพธ์ (ไทย) 2:

validationwasperformedaccordingtoUS-FDAguidance
สำหรับ industryonbioanalyticalmethodvalidation [33] Thevalida-
การ homologues.Threedaysofcalibrationcurveswitheightre- plicates ofplasmasamplesspikedwithamixtureofstandardvi- Tamin Khomologues (MK-4, PKandMK-7) overconcentration rangeof0.3-100ngmL 1 และ IS (5ngmL? 1) wereperformedto ประเมิน calibrationcurvethatcanbequantified withacceptableac- curacy andprecision.Moreover, theanalyteresponseatthiscon- centration mustbeatleast10timesthebaselinenoise (S / N¼10). limitofdetection (LOD) wasestablishedasthelowestcon- centration ofananalytethatcanbedetectedbutnotnecessarily andtheanalyteresponseatthisconcentrationmustbe ปริมาณที่least3timesthebaselinenoise (S / N¼3). Toevaluateintra-dayandinter-dayprecisionandaccuracy

ผลลัพธ์ (ไทย) 3:

fdaguidance validationwasperformedaccordingtous สำหรับ industryonbioanalyticalmethodvalidation [ 33 ] thevalida -
-
studieswerecarriedoutusingpooledplasmasamplepre tion analyzedforvitaminkcontentbeforespikingofstandardvitamin
K ใน . threedaysofcalibrationcurveswitheightre -
-
plicates ofplasmasamplesspikedwithamixtureofstandardvi Tamin khomologues ( mk-4 pkandmk-7 , ) overconcentration
rangeof0 .3-100ngml
1 และบัณฑิต สาขาวิชา 5ngml
1 ) wereperformedto
ประเมิน linearityofthedevelopedhplc flmethod . thelimitof
เซลล์ ( loq ) wasestablishedasthelowestconcentrationof
-
calibrationcurvethatcanbequantified withacceptableac ตำแหน่งผู้ดูแลพิพิธภัณฑ์ andprecision นอกจากนี้ theanalyteresponseatthiscon -
centration mustbeatleast10timesthebaselinenoise ( S / N ¼ 10 )
-
wasestablishedasthelowestcon limitofdetection ( LOD )centration ofananalytethatcanbedetectedbutnotnecessarily

ที่ andtheanalyteresponseatthisconcentrationmustbe วัด least3timesthebaselinenoise ( S / N ¼ toevaluateintra dayandinter dayprecisionandaccuracy
3 )