莫西沙星阴道泡腾片的制备和稳定性考察

Study on Preparation and Stability of Moxifloxacin Vaginal Effervescent Tablets

目的制备莫西沙星阴道泡腾片,并考察其稳定性,确定其有效期。方法通过光照、高温、低温等影响因素试验,室温留样观察,测定莫西沙星泡腾片的色泽、pH和含量变化。采用高效液相色谱法测定莫西沙星含量,色谱柱为NOVa-PaR C18柱(50 mm×3.9 mm,4μm),以1%三乙胺溶液(磷酸调pH至4.5)-乙腈(84∶16)为流动相,流速为1.0 mL/min,检测波长为296 nm。结果盐酸莫西沙星质量浓度在5～75μg/mL范围内与峰面积具有良好线性关系,r=0.998 8(n=6),平均回收率为99.26%,RSD=0.58%(n=5)。该产品对光敏感,产品在室温留样观察1年,含量仍在92.96%以上,质量稳定。结论该制剂处方合理,有效期可达2年以上。

Objective To prepare and observe the stability of moxifloxacin vaginal effervescent tablets so as to determine its expiry date. Methods The change of color, PH value and moxifloxacin content were detected through the trials of the influence factors includ- ing sunlight, high and low temperatures as well as the samples observation under the room temperature. The content of moxifloxacin was measured by high performance liquid chromatography （HPLC）. The analysis was performed on a NOVa-PaRC18 column （50 mm×3.9 mm, 4μm） with the mobile phase of 1% triethylamine （adjusted pH to 4.5 with phosphoric acid）-acetonitrile （84：16） at the flow rate of 1.0 mL/min and 296 nm as the detection wavelength. Results During the concentrations of 5-75 μg/mL,moxifloxacin showed good linear relationship with the peak area, r=0.998 8（n=6）.The average recovery rate was 99.26%, RSD 0.58% （n=5）.The products were susceptible to sunlight. The content remained above 92.96% in the 1- year observation test of the sample under the room temnerature. Conclusion The nre^arntion has a reasonable prescription with an expiry date more than 2 years.