title: Simple and rapid high performance liquid chromatography method for the determination of polidocanol as bulk product and in pharmaceutical polymer matrices using charged aerosol detection.
abstract: Currently, neither the European nor the United States Pharmacopoeia provide a method for the determination of polidocanol (PD) content despite the fact that PD, besides being an excipient, is also used as an active pharmaceutical ingredient. We therefore developed a method where the PD content was determined using a Kinetex C18 column operated at 40°C with water-acetonitrile (15:85, v/v) as mobile phase. A Corona(®) charged aerosol detector was employed for the detection of PD that is lacking a suitable UV chromophore. The method was fully validated. Additionally, the method was applied for the determination of PD release from a pharmaceutical polymer matrix consisting of poly-ɛ-caprolactone and poly(lactic-co-glycolic acid) and PD.
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, 97074 Wuerzburg, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Ilko
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, 97074 Wuerzburg, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Puhl
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, 97074 Wuerzburg, Germany.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Meinel
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, 97074 Wuerzburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Germershaus
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, 97074 Wuerzburg, Germany. Electronic address: u.holzgrabe@pharmazie.uni-wuerzburg.de.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Holzgrabe
mesh_terms: D000097:Acetonitriles; D000336:Aerosols; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000032:analysis* / Q000737:chemistry; D011108:Polymers / Q000032:analysis; D011208:Powders / Q000032:analysis; D015203:Reproducibility of Results
chemical_list: D000097:Acetonitriles; D000336:Aerosols; D011108:Polymers; D011208:Powders; D000077423:Polidocanol; D011092:Polyethylene Glycols; C032159:acetonitrile
keywords: Assay; Charged aerosol detection; Dissolution; High performance liquid chromatography; Pharmaceutical analysis; Polidocanol