氟康唑含漱液处方筛选及含量测定

Formulation screening of nystatin dihydrate gargle and its content determination

目的对氟康唑含漱液进行处方筛选,并建立RP-HPLC法测定氟康唑含量。方法用正交试验设计对处方工艺进行筛选,以RP-HPLC法测定制剂中氟康唑的含量。结果氟康唑含漱液处方合理、工艺简单、稳定性好,氟康唑检测浓度在2.0~20.0μg·m L-1与峰面积线性关系良好,回归方程Y=0.218X＋0.028,r=0.9997,精密度和回收率良好。结论氟康唑含漱液制备方法和含量测定方法简便、快速、准确,质量可控。

Objective To screen the optimal formulation of nystatin dihydrate gargle and to establish a RP-HPLC method to determine the content of nystatin dihydrate in nystatin dihydrate gargles. Methods Orthogonal design method was used to screen the optimal formulation. RP-HPLC was used to determine the content of nystatin dihydrate. Results The optimal formulation and preparation technique were simple and stable. The calibration curve of nystatin dihydrate was linear at 2.0 - 20.0 μg · mL - 1 with good accuracy and recovery. Conclusion The method is simole, quick and accurate.