复方洛美沙星即型凝胶滴耳剂的质量标准研究

目的 研究复方洛美沙星即型凝胶滴耳剂的质量标准和稳定性.方法 建立含量测定的高效液相色谱法,考察制剂的性状、pH和稳定性.结果 洛美沙星的最大吸收波长为287 nm,质量浓度在1.2- 18.15 μg/mL的范围内与峰面积呈良好线性关系(r=0.999 8),平均回收率为99.80％,RSD =0.55％(n=5);地塞米松的最大吸收波长为240nm,质量浓度在0.015 ～0.036 mg/mL的范围内与峰面积呈良好线性关系(r =0.999 9),平均回收率为99.01％,RSD=2.90％ (n=5);制剂pH为5.7,制剂稳定,含量测定不受即型凝胶空白基质的干扰.结论 制剂稳定性好,含量测定的方法可靠,质量可控.

Study on the Quality Standard of Compound Lomefloxacin In-situ Ear Gel

Objective To study the quality standard and the stability of lomefloxacin in-situ ear gel.Methods The appearance,identification and test of metronidazole in-situ vaginal gel was studied and described.The determination of metronidazole was performed with HPLC.The stability of in-situ gel and rheological properties under simulated physiological condition were investigated preliminarily.Results The prepared compound lomefloxacin in-situ ear gel was colorless or yellowish limpid liquid with character of reverse phase transformation.Its test and identification results were in conformity with the related stipulation of China Pharmacopeia（2005 edition）.The maximum absorption wavelength of lomefloxacin is 287 nm.The linear ranges of lomefloxacin by HPLC was 1.2-18.15 μg/mL（r=0.999 8）,and the average recovery was 99.80%,RSD=0.55%（n=5）.The maximum absorption wavelength of dexamethasone is 240 nm.The linear ranges of desxamethasone by HPLC was 0.015-0.036 mg/mL（r=0.999 9）,and the average recovery was 99.01%,RSD=2.90%（n=5）.The pH value is 5.7.The presence of gel base had no interference to the determination of the contents.Conclusion The quality of compound lomefloxacin in-situ ear gel is stable and controllable.The established determination methods are reliable.