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Gas Chromatographic Determination of Residual Levels of Methanol and Chloroform from Liposomal, Microspheres and Nanoparticles

Author(s): S. B. Puranik, Roopa Pai, P. N. S. Pai and G. K. Rao

The use of liposomal formulations has rapidly gained popularity in pharmaceutical research and development. Their preparation often involves the use of organic solvents such as methanol and chloroform to dissolve lipophilic lipids. In the present study, gas chromatographic method for the determination of methanol and chloroform residual levels in liposomes was developed using GC 17 A Shimadzu with FID (a flame ionization detector) and the separation was carried out on BP 624 column (4% cyanopropyl phenyl and 94% dimethyl silixone, 30 m X 0.53 mm i.d. X 0.25 μm coating thickness), with nitrogen as a carrier gas in the split mode by direct injection method. The method was validated according to ICH guidelines. The method described is simple, sensitive, rugged, reliable and reproducible and requires less time than other reported methods for the quantitation of methanol and chloroform levels from liposomal formulations of lamivudine and stavudine.

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