Demonstrative validation study employing a packed column pressurized fluid chromatography method that provides assay, achiral impurities, chiral impurity, and IR identity testing for a drug substance
| Autor: | L.T Taylor, Daryl A. Roston, D.G Williams, Tom Catalano, M Ashraf-Khorassani |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Packed bed
Chromatography Tandem Chemistry Clinical Biochemistry Analytical chemistry Reproducibility of Results Pharmaceutical Science Infrared spectroscopy medicine.disease_cause Analytical Chemistry Solutions Pharmaceutical Preparations Impurity Spectroscopy Fourier Transform Infrared Drug Discovery Supercritical fluid chromatography medicine Spectrophotometry Ultraviolet Fourier transform infrared spectroscopy Drug Contamination Quantitative analysis (chemistry) Spectroscopy Ultraviolet Chromatography Liquid |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 26:725-738 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/s0731-7085(01)00441-1 |
| Popis: | Assay development, assay validation, and documentation are reported here for a single packed column pressurized fluid chromatographic/ultraviolet (UV) method that provides: (1) simultaneous detection and quantification for the chiral drug, the chiral impurity and seven achiral impurities; and (2) a Fourier transform infrared (FT-IR) spectrometric identification test result for the Searle drug substance sample, xemilofiban. The separation is achieved in less than 30 min with three columns in tandem and a gradient of CO 2 –CH 3 OH. The post-column flow is split between UV (assay) and FT-IR (identification). Precision and accuracy are consistent within figures of merit obtained by liquid chromatographic-ultraviolet assays on analogous drug substances. The reported procedure combines three typical drug substance tests into one test (e.g. chiral impurities, achiral impurities, and infrared identification). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect