An Isocratic HPLC Method for the Determination of Sorbitol and Glycerol in Pharmaceutical Formulations

• Published in: Journal of chromatographic science Vol. 50; no. 7; pp. 644 - 647
• Main Authors: Simonzadeh, Ninus, Ronsen, Bruce
• Format: Journal Article
• Language: English
• Published: Niles, IL Oxford University Press 01.08.2012; Preston Publications
• Subjects: Acetonitriles; Analysis; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Detectors; Drug Stability; Evaporative; Excipients; Formulations; General pharmacology; Glycerol - analysis; Glycerols; Ingredients; Light scattering; Medical sciences; Pharmaceuticals; Pharmacology. Drug treatments; Reproducibility of Results; Sensitivity and Specificity; Sorbitol; Sorbitol - analysis; Sorbitol; Validation; Alditol; Chemical analysis; Ultraviolet detector; HPLC chromatography; Dosage form; Glycerol; Evaporative light scattering detector; Isocratic condition; Quantitative analysis
• DOI: 10.1093/chromsci/bms044
• ISSN: 0021-9665

Sorbitol and glycerol, along with other inactive ingredients such as preservatives and dyes, are commonly used in various pharmaceutical and personal care products. To accurately assess the effectiveness of various formulations containing sorbitol and/or glycerol, their quantitative determination is essential. In the current study, two types of detectors (a Varian evaporative light scattering detector and an Agilent ultraviolet-visible detector) are evaluated for the assay of working sample solutions. The two detection techniques are complimentary, and a comparison of the results obtained using the two detectors is presented here. The current method is shown to be stability-indicating and free from interference from any of the formulation excipients and potential degradation products. The method is reproducible, accurate, sensitive and selective. It provides enhanced detection sensitivity for sorbitol and comparable sensitivity for glycerol versus similar methods reported in the literature that utilize a refractive index detector for the analysis of either of the two polyols.