A VALIDATED HPLC METHOD FOR DETERMINATION OF TIOCONAZOLE LOADED VAGINAL IMPLANTS PREPARED BY HOT MELT EXTRUSION

Betül Rumeysa Temel, Seda Rençber and I??k Özgüney*

ABSTRACT

Vaginal candidiasis is a common mucosal infection of vagina, mainly caused by Candida species. Tioconazole is an imidazole derivative which is therapeutically used as an antifungal drug. At present study, Tioconazole loaded vaginal implant was prepared using hot melt extrusion method. The routine control analysis of Tioconazole requires rapid, reliable, accurate and precise method for the quantification of the drug in vaginal implant formulation. A simple, rapid and precise reverse phase high performance liquid chromatographic (HPLC) method has been developed for the simultaneous determination of Tioconazole. The method was validated according to ICH guidelines. Validation parameters were linearity, specificity, accuracy, precision (repeatability and reproducibility), limit of detection, limit of quantification and short term stability. Under the optimum reaction conditions, linear relationships with appreciable correlation coefficient (0.9999) were found at 224 nm and the concentration of Tioconazole in the range of 0.5-160 μg/mL.

Keywords: Hot melt extrusion, HPLC method, PLGA, Tioconazole, vaginal implant.