PMID- 34058536
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 1873-264X (Electronic)
IS  - 0731-7085 (Linking)
VI  - 202
DP  - 2021 Aug 5
TI  - Chemometric evaluation of repeatability of internal standard methods in 
      high-performance liquid chromatography with a Japanese pharmacopoeia assay for 
      indomethacin as an example.
PG  - 114165
LID - S0731-7085(21)00276-4 [pii]
LID - 10.1016/j.jpba.2021.114165 [doi]
AB  - The purpose of this study is to elucidate uncertainty structures of internal 
      standard (IS) methods as compared with absolute calibration methods in liquid 
      chromatography. A quantitative test of indomethacin with butyl 4-hydroxybenzoate 
      as an IS in high-performance liquid chromatography with ultra-violet detection is 
      taken here as an example. The repeatability is evaluated by both a usual 
      statistical method of repetition and a theoretical approach, called the function 
      of mutual information (FUMI) theory. The latter predicts the precision from noise 
      and signals of instrumental output. Plots of relative standard deviations (RSDs) 
      of measurements against analyte amounts, called precision profiles, are compared 
      between the IS methods for indomethacin and their corresponding absolute 
      calibration methods over a wide range of amount. Sample injection errors are 
      observed to be effectively eliminated at high amounts by the IS methods, but at 
      low amounts where background random noise dominates over the other error, the 
      superiority of the IS methods is overshadowed and the precision of both the 
      methods is almost comparable. The smallest possible amount of IS material without 
      spoiling the integrity of analysis is estimated from the precision profiles.
CI  - Copyright (c) 2021 Elsevier B.V. All rights reserved.
FAU - Kotani, Akira
AU  - Kotani A
AD  - School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 
      Horinouchi, Hachioji, Tokyo, 192-0392, Japan. Electronic address: 
      kotani@toyaku.ac.jp.
FAU - Hakamata, Hideki
AU  - Hakamata H
AD  - School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 
      Horinouchi, Hachioji, Tokyo, 192-0392, Japan.
FAU - Hayashi, Yuzuru
AU  - Hayashi Y
AD  - Institute for FUMI Theory, 3-3-15 Inaridai, Sakura, Chiba, 285-0864, Japan.
LA  - eng
PT  - Journal Article
DEP - 20210524
PL  - England
TA  - J Pharm Biomed Anal
JT  - Journal of pharmaceutical and biomedical analysis
JID - 8309336
RN  - XXE1CET956 (Indomethacin)
SB  - IM
MH  - Calibration
MH  - Chromatography, High Pressure Liquid
MH  - Chromatography, Liquid
MH  - *Indomethacin
MH  - Japan
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - FUMI theory
OT  - Injection volume
OT  - Internal standard method
OT  - Liquid chromatography
OT  - Relative standard deviation
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2021/06/01 06:00
MHDA- 2021/06/22 06:00
CRDT- 2021/05/31 20:19
PHST- 2021/03/16 00:00 [received]
PHST- 2021/05/07 00:00 [revised]
PHST- 2021/05/20 00:00 [accepted]
PHST- 2021/06/01 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2021/05/31 20:19 [entrez]
AID - S0731-7085(21)00276-4 [pii]
AID - 10.1016/j.jpba.2021.114165 [doi]
PST - ppublish
SO  - J Pharm Biomed Anal. 2021 Aug 5;202:114165. doi: 10.1016/j.jpba.2021.114165. Epub 
      2021 May 24.