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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 validity of Lomefloxacin Hydrochloride Eardrops to expand the clinical application of Lomefloxacin and to increase the use of otology. Methods: The content of the preparation was determined by ultraviolet spectrophotometry. The stability was discussed by classical thermostat method and Weibull probability method. Results: The average recovery of the product was 99.80% and the RSD was 0.66% by UV spectrophotometry. The classical thermostat method predicts that the preparation has a validity period of 5.16 years when stored at pH 5-6,25 ℃, and the Weibul Probability Method predicts its validity period is 4.98 years. Conclusion: UV spectrophotometry Lomefloxacin Hydrochloride Eardrops fast and easy, good precision, high reliability. In the absence of direct sunlight stored at room temperature the preparation of good stability.