title: Use of evaporative light scattering detection for the quality control of drug substances: influence of different liquid chromatographic and evaporative light scattering detector parameters on the appearance of spike peaks.
abstract: High performance liquid chromatography (HPLC) with evaporative light scattering detection (ELSD) is a versatile, easy to use and inexpensive alternative when it comes to the analysis of substances lacking a chromophor for UV detection. However, in pharmaceutical analysis injection of highly concentrated test solutions are normally required to control impurities at low levels. Under these conditions spike peaks were observed in the chromatograms of the test solutions making a proper evaluation of the impurity profile impossible. The influence of different eluent and ELSD parameters such as eluent composition, eluent flow-rate, ELSD scavenger gas flow-rate and evaporation temperature on the appearance of spike peaks was investigated. It could be shown that spike peaks can be avoided when selecting elevated eluent flow-rates and ESLD scavenger gas flow-rates. Moreover, eluents containing high amounts of organic modifier seem to foster the appearance of spike peaks.
authors.affiliation: European Directorate for the Quality of Medicines and Health Care, Allée Kastner, 67081 Strasbourg, France.
authors.forename: Stefan
authors.initials: S
authors.lastname: Almeling
authors.forename: Ulrike
authors.initials: U
authors.lastname: Holzgrabe
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D017022:Flow Injection Analysis / Q000379:methods*; D008027:Light; D009330:Nebulizers and Vaporizers; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D012542:Scattering, Radiation; D012680:Sensitivity and Specificity; D013696:Temperature
chemical_list: D004364:Pharmaceutical Preparations