A simple,specific,accurate and precise spectrophotometric stability indicating method is developed for determination of itraconazole in the presence of its oxidative degradation product and in pharmaceutical formulati...A simple,specific,accurate and precise spectrophotometric stability indicating method is developed for determination of itraconazole in the presence of its oxidative degradation product and in pharmaceutical formulations.A newly developed spectrophotometric method called ratio difference method by measuring the difference in amplitudes between 230 and 265nm of ratio spectra.The calibration curve is linear over the concentration range of 5~25μg·mL-1 with mean percentage recovery of 99.81±1.002.Selective quantification of itraconazole,singly in bulk form,pharmaceutical formulations and in the presence of its oxidative degradation product is demonstrated.The results have been statistically compared with a pharmacopeial method.展开更多
The smart novel ratio difference spectrophotometric method was developed and validated for the determination of a binary mixture of Sodium cromoglicate (SCG) and Fluorometholone (FLU) in presence of benzalkonium chlor...The smart novel ratio difference spectrophotometric method was developed and validated for the determination of a binary mixture of Sodium cromoglicate (SCG) and Fluorometholone (FLU) in presence of benzalkonium chloride without prior separation. The results were compared to that of the conventional methods (dual wavelength and first derivative of ratio spectra). The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution. The novel method showed significant advantages over the conventional methods regarding simplicity, minimal data manipulation and maximum reproducibility and robustness;which enabled the analysis of binary mixtures with overlapped spectra for routine quality control testing with quite satisfactory.展开更多
文摘A simple,specific,accurate and precise spectrophotometric stability indicating method is developed for determination of itraconazole in the presence of its oxidative degradation product and in pharmaceutical formulations.A newly developed spectrophotometric method called ratio difference method by measuring the difference in amplitudes between 230 and 265nm of ratio spectra.The calibration curve is linear over the concentration range of 5~25μg·mL-1 with mean percentage recovery of 99.81±1.002.Selective quantification of itraconazole,singly in bulk form,pharmaceutical formulations and in the presence of its oxidative degradation product is demonstrated.The results have been statistically compared with a pharmacopeial method.
文摘The smart novel ratio difference spectrophotometric method was developed and validated for the determination of a binary mixture of Sodium cromoglicate (SCG) and Fluorometholone (FLU) in presence of benzalkonium chloride without prior separation. The results were compared to that of the conventional methods (dual wavelength and first derivative of ratio spectra). The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution. The novel method showed significant advantages over the conventional methods regarding simplicity, minimal data manipulation and maximum reproducibility and robustness;which enabled the analysis of binary mixtures with overlapped spectra for routine quality control testing with quite satisfactory.
