高效液相色谱法测定痛特灵霜中双氯芬酸的含量  

Determination of diclofenac in its cream by high performance liquid chromatography

作　　者：赵玉兰[1] 李楠[1] 王新熙 王晓燕[1] 郭代红[1] 梁明林[1] 

机构地区：[1]中国人民解放军总医院中心仪器室,中国人民解放军总医院制剂室

出　　处：《中国医院药学杂志》1995年第11期507-508,共2页Chinese Journal of Hospital Pharmacy

摘　　要：本文采用ＨＰＬＣ法，建立了痛特灵霜中双氯芬酸的含量测定方法。用地塞米松为内标，样品加超纯水超声振荡提取后，用０．４５μｍ滤膜滤过，进样１０μｌ，采用国产ＹＷＧ－Ｃ＿（１８）柱分离，甲醇：水：醋酸（８０：２０：２）的混合溶液为流动相，２７５ｎｍ波长处检测。样品保留时间为４．６３ｍｉｎ。标准曲线浓度在０．５～４０μｇ／ｍｌ范围内线性关系良好（ｒ＝０．９９９９）。最低检测浓度为０．１２５μｇ／ｍｌ。方法的绝对回收率平均为９８％（ｎ＝６），ＲＳＤ为１．８％。相对回收率平均为９９．８％（ｎ＝６），ＲＳＤ＝１．０％。日内ＲＳＤ为０．５％～１．８％，日间ＲＳＤ为０．８％～６．５％。测定三批样品，平均百分含量为９７．９９％。Tong- te- ling shuang is a new anti- inflammatory and analgesic agent.This paper describes a sensitive and re-producible HPLC method for the determination of diclofenac in the preparation. The assay technique utilized simpleultrapure water extraction. Dexamethasone was used as the internal standard.Chromatography was carried outwith a YWG-C_(18)(10μm),the mobile phase was a mixture of methanol- water- acetic acid (80 :20 :2).The flow-rate was 1.0ml/min. The column eluent was monitored at 275nm. the detection limit was 0.1250μg/ml.the lin-earity range was 0.5-40μg/ml(r=0.9999).The method showed good precision;the within-day relative standarddeviation(RSD)was 0.53%～1.79%. The between-day RSD was 0.8%～6.5%.the average recovery was 98.0 ±1.8%(n=6).

关 键 词：双氯芬酸 高效液相色谱法 痛特灵霜 

分 类 号：R971.1[医药卫生—药品] R927.2[医药卫生—药学]