Ruggedness study of HPLC peptide mapping for the identity of a drug compound: A chemometrics approach

被引:6
作者
Lee, KR
Bongers, J
Jones, BH
Burman, S
机构
[1] SmithKline Beecham Pharmaceut, Dept Stat Sci, King Of Prussia, PA 19406 USA
[2] SmithKline Beecham Pharmaceut, Bioanalyt Sci Dept, King Of Prussia, PA 19406 USA
关键词
peptide mapping; principal component analysis; ruggedness study;
D O I
10.1081/DDC-100100337
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A statistically more reliable approach than the traditional visual inspection of peptide maps to identify a drug compound is to generate a set of reference standards from a designed experiment that incorporates many possible factors that affect variation of peptide mapping. In fact, the experiment can be done for a ruggedness study as part of a high-performance liquid chromatography (HPLC) method validation. Once the ruggedness is proved with the study, those articles in the experiment may form a set of reference standards, and future articles can be compared to the set later to prove identity. A quantitative analysis of the ruggedness study can be done using a chemometrics approach, principal component analysis (PCA). The analysis is used to reduce the many channels of peptide maps to a few manageable dimensions. The scores projected onto the reduced dimensions are used to test factor effects of the ruggedness study. As a by-product, the analysis provides visual inspection of the set of articles in the experiment for any outliers and anomalies.
引用
收藏
页码:123 / 134
页数:12
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