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

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...

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Bibliographic Details
Published inJournal of chromatographic science Vol. 50; no. 7; pp. 644 - 647
Main Authors Simonzadeh, Ninus, Ronsen, Bruce
Format Journal Article
LanguageEnglish
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
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Summary: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.
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ISSN:0021-9665
1945-239X
DOI:10.1093/chromsci/bms044