氟比洛芬滴眼液中氟比洛芬与防腐剂的含量测定及稳定性考察  

Content determination of flurbiprofen and preservative in flurbiprofen ophthalmic solution and stability study

作　　者：刘薇[1] 李建文[2] 桑艳双[1] 徐淑英[1] 徐士钊[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]华瑞制药有限公司,北京100005

出　　处：《沈阳药科大学学报》2008年第10期800-805,共6页Journal of Shenyang Pharmaceutical University

摘　　要：目的制定氟比洛芬滴眼液中主药及防腐剂的含量测定方法并进行稳定性考察，预测室温存放的有效期。方法采用RP-HPLC法测定主药及防腐剂的含量，用恒温加速法预测其有效期。结果氟比洛芬质量浓度在6．0～72mg·L^-1内、羟基苯甲酸乙酯质量浓度在7．5～90mg·L^-1内与吸光度呈良好的线性关系；氟比洛芬平均回收率为100．0％，RSD为0．62％；羟基苯甲酸乙酯平均回收率为99．9％，RSD为0．70％。氟比洛芬在室温25℃下的有效期（t0.9）为3.7年，羟基苯甲酸乙酯在室温25℃下的有效期为1．9年。结论建立的含量测定及贮存期预测的方法简便、快速、准确、可靠，适用于制剂的质量控制。Objective To establish a method for determining the contents of flurbiprofen and preservative in flurbiprofen ophthalmic solution and to forecast its expiration date at room temperature. Methods RP-HPLC was developed for the determination of flurbiprofen and preservative in the eye drops. The expiration date of the eye drops was determined by classical constant temperature. Results The assay was linear for flurbiprofen within a range of 6.0 - 72 mg·L^-1, and for ethyl hydroxybenzoate within a range of 7.5 - 90 mg·L^-1. The mean recovery of flurbiprofen was 100.0 % , RSD was 0.62 %. The mean recovery of ethyl hydroxybenzoate was 99.9 % , RSD was 0.70 %. The expiration date（t0.9） for flurbiprofen at 25 ℃ was 3.7 years, and that for ethyl hydroxybenzoate at 25 ℃ was 1.9 years. Conclusions The method is simple, rapid, and accurate, and can be used for the quality control of flurbiprofen ophthalmic solution.

关 键 词：氟比洛芬滴眼液 氟比洛芬 羟基苯甲酸乙酯 稳定性 

分 类 号：R917[医药卫生—药物分析学]