Quality evaluation of fluconazole-loaded cubic ohase gels / 军事医学

ABSTRACT

Objective To characterize the internal structures of fluconazole-loaded cubic phase gels and establish a method for determination of fluconazole.Methods Glycerol monooleate( GMO) was used as the liquid crystal material to prepare the fluconazole loaded cubic phase gels.Polarizing light microscopy ( PLM ) and small-angle X-ray scattering ( SAXS) were used to confirm their internal structures and establish an HPLC method for determination of their content. Results Cubic phase gels were the dark field under PLM,SAXS showed that the blank cubic phase gels had two single peaks:q1(0.832 09 nm-1 ) and q2 (1.017 nm-1 ) while the fluconazole-loaded cubic phase gels had two single peaks:q1(0.818 88 nm-1)and q2(0.950 95 nm-1).Under the selected HPLC, the linearity within the range of 20-500 μg/ml was good.Conclusion PLM and SAXS are reliable for characterization of cubic phase gels.The HPLC method can be used in quality control and evaluation of this enema.