期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 219, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.jpba.2022.114942
关键词
PTH; Quality control; Protein content; CE-UV; LC-UV; LC-MS
The study aimed to compare 1-84 parathyroid hormone (PTH) standards from different manufacturers to the WHO international standard, while investigating CE and LC methods as quick and inexpensive quantitation methods. The research also revealed that some 1-84 PTH standards have content twice as high as indicated on the label.
Relative quantitation methods rely on the use of reference substances to determine the content of samples. The aim of this study was to compare 1-84 parathyroid hormone (PTH) standards from different manufacturers to the WHO international standard 95/646. CE and LC with UV detection were investigated as quick and inexpensive quantitation methods, with an emphasis on selectivity between intact 1-84 PTH and its oxidized forms. Both methods were fully validated according to ICH Q2R1. Moreover, method performance was also evaluated ac-cording to guidelines defining the maximum allowable measurement uncertainty (MU) of a biological parameter from its intraindividual variation (CVI), as well as the proportion of that MU devoted to the reference material. This study highlighted the fact that some 1-84 PTH standards have a content that is actually twice as high as the one stated on the label, which was confirmed by an amino acid analysis investigation. Our approach offers a quick and inexpensive way to estimate the content of 1-84 PTH standards.
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