High-performance liquid chromatography of lactose with evaporative light scattering detection, applied to determine fine particle dose of carrier in dry powder inhalation products

• Published in: Journal of Chromatography A Vol. 1107; no. 1; pp. 204 - 207
• Main Authors: Beilmann, Bianca, Langguth, Peter, Häusler, Heribert, Grass, Peter
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 24.02.2006; Elsevier
• Subjects: Administration, Inhalation; Aminopropyl column; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Dry powder inhalation products; Evaporative light scattering detection; General pharmacology; Lactose; Lactose - analysis; Light; Medical sciences; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Powders - chemistry; Reproducibility of Results; Scattering, Radiation; Dry powder inhalation products; Aminopropyl column; Lactose; Evaporative light scattering detection; Delivery system; Validation; Dry powder inhaler; Chemical analysis; Vehicle(excipient); HPLC chromatography; Drug carrier; Disaccharide; Aminopropyl column: Dry powder inhalation products; Fine particle; Evaporative light scattering detector; Quantitative analysis
• ISSN: 0021-9673
• DOI: 10.1016/j.chroma.2005.12.083

A method for quantification of the fine particle dose of lactose is described, using a hydrophilic interaction chromatography (HILIC) method and evaporative light scattering detection. The HILIC method used an aminopropyl column and a mobile phase consisting of acetonitril/water (80/20, v/v) for isocratic elution. Sensitive chromatography was obtained using a low concentration of water in the extraction solvent. The detection limit (RSD < 10%) at an injection volume of 10 μL is 10 μg/mL. Linearity was obtained in the range of 10–80 μg/mL ( R 2 > 0.99). A relative standard deviation (RSD) of 0.5% ( N = 6) demonstrated good precision of the optimized method.