Investigation of pharmaceutical high-performance liquid chromatography assay bias using experimental design.
This article presents a systematic approach to investigate, document, and eliminate pharmaceutical HPLC assay bias using experimental design. This is the first article to describe the application of experimental design in the area of assay bias. It is found that both formulation and analytical variables can contribute to pharmaceutical HPLC assay bias using model compounds and formulations.
Chen
J G
JG
DuPont Pharmaceuticals Company, Wilmington, DE 19880-0353, USA. jian-ge.chen@spcorp.com
Glancy
K
K
Chen
X
X
Alasandro
M
M
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D004364:Pharmaceutical Preparations