双氯灭痛滴眼液的含量测定及其稳定性研究  

DETERMINATION OF DICLOFENAC SODIUM IN OPHTHALMIC SOLUTION BY UV-SPECTROPHOTOMETRY AND STUDIES ON ITS STABILITY BY HPLC

作　　者：王娅娟[1] 祁学永[1] 李斌[1] 

机构地区：[1]山东教育学院化学系

出　　处：《山东师范大学学报（自然科学版）》1996年第4期56-60,共5页Journal of Shandong Normal University(Natural Science)

摘　　要：用紫外光谱法测定双氯灭痛的含量和ＨＰＬＣ法研究其稳定性．在０００２ｍｏｌ／Ｌ氢氧化钠溶液中双氯灭痛于２７６±１ｎｍ波长处有最大吸收，其吸光度与浓度在５～３０μｇ／ｍｌ范围内呈良好线性关系．回收率实验的相对标准偏差为０５％．ＨＰＬＣ法采用ＮｕｃｌｅｏｓｉｌＣ１８柱，以甲醇—水（５０∶５０）为流动相．实验结果表明滴眼液在强光照射和高温下贮存不稳定。The determination of Diclofenac Sodium in ophthalmic solution by UV-spectrophotometry was reported and its stability by HPLC was studied.The wavelength of the detection was 276 nm and the standard curve was linear over the concentration between 5 and 30 μg/ml with the correlation coefficient 0.997 4.The coefficient of variation of the recovery was 0.5% .Chromatographic conditions were as follows:column,Nuclesil C 18 ;mobile phase,methanol-water(50∶50);flow rate, l ml/min; UV detection wavelength∶277 nm.It was found that Diclofenac Sodium in ophthalmic solution was found that Diclofenac Sodium in ophthalmic solution was unstable under sunlight and at relatively high temperature.The stability test showed Diclofenac Sodium in opthalmic solution stored at room temperature for 4.7 years with decomposition of 10%.

关 键 词：双氯灭痛 高效液相色谱 稳定性 滴眼液 

分 类 号：R988.1[医药卫生—药品]