title: Gas chromatographic determination of residual levels of tert.-butanol from lyophilized liposomal formulations.
abstract: The use of liposomal formulations is rapidly gaining popularity in pharmaceutical research and development. Their preparation often involves the use of organic solvents such as tert.-butanol to dissolve lipophilic lipids. To improve the physicochemical stability of the liposomes, lyophilizing the product is one of the best available means. A gas chromatographic method for the determination of tert.-butanol residual levels in lyophilized liposomes, employing sec.-butanol as internal standard, using a flame ionization detector (FID) detector and a cross-linked dimethylpolysiloxane capillary column, was developed. The method described is simple, sensitive, rugged, reliable and reproducible and requires less time than other reported methods for the quantitation of tert.-butanol; it also has pharmaceutical applications.
authors.affiliation: Center for Pharmaceutical Science and Technology, College of Pharmacy, University of Kentucky, Lexington 40536-0082.
authors.forename: P V
authors.initials: PV
authors.lastname: Gogineni
authors.forename: P A
authors.initials: PA
authors.lastname: Crooks
authors.forename: R B
authors.initials: RB
authors.lastname: Murty
mesh_terms: D000440:Butanols / Q000032:analysis*; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D002849:Chromatography, Gas / Q000379:methods*; D004355:Drug Stability; D005612:Freeze Drying; D008081:Liposomes / Q000032:analysis*; D012997:Solvents; D014050:Toluene; D020002:tert-Butyl Alcohol
chemical_list: D000440:Butanols; D008081:Liposomes; D012997:Solvents; D014050:Toluene; D020002:tert-Butyl Alcohol