Formulation Design and Content Determination of Thermosensitive Secnidazole Hydrogels / 中国药房

ABSTRACT

OBJECTIVE:To select the optimal formulation of thermosensitive secnidazole hydrogels and establish its determination method. METHODS:Formulation was optimized by orthogonal design with the content of poloxamer P407/P188(A),ethanol (B)and sodium alginate(C)as factors and with secnidazole as index. The content of secnidazole in preparation was determined by UV spectrometry at detection wavelength of 277 nm. RESULTS:The optimal formulation was as followsA of 15 g/15 g,B of 20 mL and C of 0.6 g. The linear range of secnidazole was 4.618～46.18 mg?L-(1r=0.999 8)with an average recovery of 98.27%. The RSD of intra-day and inter-day were both lower than 1.8% and 2.1% respectively. CONCLUSIONS:The formulation is reasonable and the process was reliable and controllable in quality.