Validated methods for determination of some antifungal drugs / Ramia Gamal Elsayed Elganyany ; Supervised Ramzia Ismail Elbagary , Marianne Alphonse Mahrouse , Maha Medhat Elhakeem

Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Pharmaceutical Chemistry

Butoconazole nitrate and ciclopirox olamine are topical antifungal, (HPLC) method for the analysis of Butoconazole nitrate BUT in drug substance and in drug product was developed and validated. The method is based on isocratic HPLC separation of BUT from its oxidation degradation product DEG1 using a mobile phase consisting of methanol: phosphate buffer (20 mM adjusted to pH 6.5 with o-phosphoric acid): triethylamine (80: 20: 0.1, v/v /v). The flow rate was maintained at 1.5 ml/min. UV spectrophotometric detection was carried out at 270 nm. TLC- densitometric method was described for the determination of butoconazole nitrate BUT in presence of its oxidation degradation product DEG1, in drug substance and in drug product. The suitable developing system to achieve the best separation was hexane: ethyl acetate: Methanol (7: 3: 0.85, v/v/v). The scanning of the spots was performed at 276 nm. A multiple divisor ratio difference spectrophotometric method is proposed for the simultaneous determination of BUT. The differences in peak amplitudes at two different wavelengths namely, 259 nm and 277 nm ({uF072}P277- 259 nm) of ratio spectra were measured. A muliple divisor ratio spectrophotometric method is proposed for the simultaneous determination of Butoconazole nitrate BUT. The ratio spectra were obtained by dividing the absorption spectra of different concentrations of the spectrum of BUT by the sum of the absorption spectra of MP, PP and DEG1 as a multiple divisor. The first derivative of the obtained ratio spectrum of BUT was then recorde

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