盐酸洛美沙星滴耳剂稳定性研究

Stability of lomefloxacin hydrochloride ear drops

目的：预测盐酸洛美沙星滴耳剂有效期，用以扩大洛美沙星的临床应用，增加耳科用药。方法：采用紫外分光光度法测定制剂含量，用经典恒温法和Ｗｅｉｂｕｌ概率法探讨其稳定性。结果：紫外分光光度法测定制剂含量平均回收率为９９．８０％，ＲＳＤ为０．６６％。经典恒温法预测本制剂在ｐＨ为５～６，２５℃贮存时有效期为５．１６年，Ｗｅｉｂｕｌ概率法预测其有效期为４．９８年。结论：紫外分光光度法测定盐酸洛美沙星滴耳剂快速简便，精密度好，可靠性高。在无阳光直射条件下室温贮存本制剂稳定性好。

OBJECTIVE: To predict the stability of lomefloxacin hydrochloride ear drops. METHODS: The drops were determined using UV spectrophotometry. Classical isothermal method and Weibull probability paper method were used to determine the stability of the ear drops. RESULTS: The average recovery of lomefloxacin from the ear drops was 99.80%, and the average relative standard deviation (RSD) was 0.66%. After using classical isothermal method and Weibull probability paper method, the shelf life of the lomefloxacin ear drops was 5.16 years and 4.98 years respectively. CONCLUSION: The analysis method of UV spectrometry was rapid and precise. Being stored away from direct sunlight, the stability of lomefloxacin ear drops is good.