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目的建立HPLC法测定利巴韦林雾化吸入液中利巴韦林含量的方法,并对其体外沉积率进行考察。方法采用SB-AQ C18色谱柱(250mm×4.6mm,5μm),流动相为水,流速:1.0ml·min~(-1),检测波长:207nm。采用新一代多级药用撞击器测定利巴韦林雾化吸入液的有效部位沉积率。结果在41.6~416μg·ml~(-1)范围内,峰面积对质量浓度有良好的线性关系,日内精密度和日间精密度均<2%(n=5);回收率在98%~102%;体外沉积率为68.51%。结论本含量测定方法准确可靠、重复性好,该制剂的体外肺沉积率符合要求。
OBJECTIVE To establish a HPLC method for the determination of ribavirin in nebulized solution of ribavirin and investigate its deposition rate in vitro. Methods The SB-AQ C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was water and the flow rate was 1.0 ml · min -1. The detection wavelength was 207 nm. Adopting a new generation of multi-stage medical impactor to measure the effective deposition rate of ribavirin inhalation solution. The results showed that there was a good linear relationship between the peak area and mass concentration in the range of 41.6 ~ 416μg · ml ~ (-1), the intra-day precision and intra-day precision were less than 2% (n = 5) 102%; in vitro deposition rate of 68.51%. Conclusion The content determination method is accurate and reproducible, and the in vitro pulmonary deposition rate of the preparation meets the requirements.