Investigation of response factor ruggedness for the determination of drug impurities using high-performance liquid chromatography with ultraviolet detection

Quantification of impurities in drug substances and dosage forms using HPLC assays with UV detection is often done by comparison to a standard of the drug itself. Depending on the spectra of the compounds involved, small changes in wavelength may cause response factors to vary from day to day and in...

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Veröffentlicht in:Journal of Chromatography A 1997-02, Vol.762 (1), p.227-233
Hauptverfasser: Olsen, Bernard A., Argentine, Mark D.
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container_title Journal of Chromatography A
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Argentine, Mark D.
description Quantification of impurities in drug substances and dosage forms using HPLC assays with UV detection is often done by comparison to a standard of the drug itself. Depending on the spectra of the compounds involved, small changes in wavelength may cause response factors to vary from day to day and instrument to instrument. Lack of assay ruggedness with respect to wavelength can lead to poor reproducibility of results. Response factor ruggedness was investigated for potential impurities in LY297802 tartrate, a potent muscarinic agonist. The UV responses of some impurities at 280 nm, the analytical detection wavelength, differ from that of the parent and change significantly with small shifts in wavelength. The ruggedness of response factors was examined on a single detector and among several different detectors. Results varied significantly among the different detectors. The UV spectra of the impurities could be used to predict the effect of wavelength on ruggedness of response. A wavelength system suitability sample is proposed as a way to overcome variability due to small differences in detector wavelength.
doi_str_mv 10.1016/S0021-9673(96)00678-4
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source MEDLINE; Elsevier ScienceDirect Journals
subjects Analysis
Biological and medical sciences
Chemistry, Pharmaceutical - methods
Cholinergic Agents - chemistry
Chromatography, High Pressure Liquid - methods
Detector wavelength ruggedness
Drug Contamination
General pharmacology
Linear Models
LY297802
Medical sciences
Pharmaceutical Preparations - chemistry
Pharmacology. Drug treatments
Reproducibility of Results
Response factors
Spectrophotometry, Ultraviolet
Thiadiazoles - chemistry
title Investigation of response factor ruggedness for the determination of drug impurities using high-performance liquid chromatography with ultraviolet detection
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