Quantitative determination of polysorbate 20 in nasal pharmaceutical preparations by high-performance liquid chromatography

Zsolt Õszi, G. Pethő

Research output: Contribution to journalArticle

Abstract

A specific reversed-phase HPLC method has been developed for the quantitative determination of polysorbate 20 (1) in various compositions of nasal solutions. This method is based on the acidic hydrolysis of the sorbitan laurate followed by the HPLC determination of the free acid. Using this method (1) can effectively be separated and quantitatively determined in matrices containing a wide variety of preservatives, surfactants, and viscosity agents. Sample preparation involves a one-step hydrolysis with sulfuric acid, and a dilution with acetonitrile prior to injection. 20 μl of the resulting mixture is analysed using different brands of 5-μm octadecylsilane reversed-phase columns with a mobile phase of acetonitrile : 0.025 M aqueous di-Sodium hydrogen phosphate, pH=2.8 (75:25). The column effluent is monitored by UV detection at 210 nm. The validity of the method has been verified with specificity, linearity, accuracy, method- and system precisions data. The method is linear from 2.5 mg/ml to 125 mg/ml of (1). Recovery is determined from spiked samples containing 80-100-120 % of the label claim. Limit of Detection and Limit of Quantitation are 0.041 mg/ml and 0.060 mg/ml respectively. Method ruggedness is tested by a second analyst using a different column and instrument. The actual results obtained with this method will be presented.

Original languageEnglish
Pages (from-to)230
Number of pages1
JournalJournal de Pharmacie de Belgique
Volume53
Issue number3
Publication statusPublished - 1998

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Polysorbates
Nose
High Pressure Liquid Chromatography
Pharmaceutical Preparations
Hydrolysis
Laurates
Information Systems
Surface-Active Agents
Viscosity
Limit of Detection
Hydrogen
Injections
Acids

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

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title = "Quantitative determination of polysorbate 20 in nasal pharmaceutical preparations by high-performance liquid chromatography",
abstract = "A specific reversed-phase HPLC method has been developed for the quantitative determination of polysorbate 20 (1) in various compositions of nasal solutions. This method is based on the acidic hydrolysis of the sorbitan laurate followed by the HPLC determination of the free acid. Using this method (1) can effectively be separated and quantitatively determined in matrices containing a wide variety of preservatives, surfactants, and viscosity agents. Sample preparation involves a one-step hydrolysis with sulfuric acid, and a dilution with acetonitrile prior to injection. 20 μl of the resulting mixture is analysed using different brands of 5-μm octadecylsilane reversed-phase columns with a mobile phase of acetonitrile : 0.025 M aqueous di-Sodium hydrogen phosphate, pH=2.8 (75:25). The column effluent is monitored by UV detection at 210 nm. The validity of the method has been verified with specificity, linearity, accuracy, method- and system precisions data. The method is linear from 2.5 mg/ml to 125 mg/ml of (1). Recovery is determined from spiked samples containing 80-100-120 {\%} of the label claim. Limit of Detection and Limit of Quantitation are 0.041 mg/ml and 0.060 mg/ml respectively. Method ruggedness is tested by a second analyst using a different column and instrument. The actual results obtained with this method will be presented.",
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