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  • Title: Gas chromatographic determination of residual levels of tert.-butanol from lyophilized liposomal formulations.
    Author: Gogineni PV, Crooks PA, Murty RB.
    Journal: J Chromatogr; 1993 Oct 22; 620(1):83-8. PubMed ID: 8106595.
    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.
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