HPLC法同时测定复方克林霉素膜中三种有效成分的含量  

Determination of Three Effective Components in Compound Clindamycin Membrane by HPLC

作　　者：危雪平 王鹏远 郭飞燕 王晓娟 

机构地区：[1]陕西中医学院,陕西西安712046 [2]第四军医大学口腔医院药剂科军事口腔医学国家重点实验室,陕西西安710032

出　　处：《解放军药学学报》2014年第6期516-518,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高计划;No.13ZJZ08

摘　　要：目的建立HPLC法同时测定复方克林霉素膜中克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁的含量。方法采用Diamonsil C18（150 mm×4.6mm,5μm）色谱柱,流动相：乙腈（A）-0.2%磷酸水溶液（B）,梯度洗脱,检测波长：230 nm,流速：1.0 ml·min-1,柱温：25℃。结果克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁分别在0.30~3.00 mg·ml-1（r=0.9997）、1.30~13.00μg·ml-1（r=0.9998）和16.00~160.00μg·ml-1（r=0.9999）范围内与峰面积线性关系良好;平均加样回收率分别为98.45%、98.89%和99.22%,RSD分别为0.83%、1.27%和0.67%（n=9）。结论本方法结果准确,专属性强,可用于复方克林霉素膜中克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁的含量测定。Objective To establish an HPLC method for content determination of clindamycin phosphate,dexamethasone sodium phosphate and dyclonine hydrochloride in compound clindamycin membrane.Methods Diamonsil C18column（150 mm × 4.6 mm,5 μm） was used with the mobile phase consisting of acetonitrile-0.2% phosphoric acid in a gradient manner at a flow rate of 1.0 ml·min-1.The detection wavelength was set at 230 nm while the column temperature was at 25 ℃.Results Good linear correlations were observed within the range of 0.30-3.00 mg·ml-1for clindamycin phosphate（r = 0.9997）,1.30-13.00 μg·ml-1for dexamethasone sodium phosphate（r = 0.9998） and16.00-160.00 μg·ml-1for dyclonine hydrochloride（r = 0.9999）.The average recovery（n = 9） was 98.45%（RSD =0.83%）,98.89%（RSD =1.27%） and 99.22%（RSD =0.67%）,respectively.Conclusion This method,accurate and specific,can be used for content determination of clindamycin phosphate,dexamethasone sodium phosphate and dyclonine hydrochloride in compound clindamycin membrane.

关 键 词：HPLC 复方克林霉素膜 克林霉素磷酸酯 地塞米松磷酸钠 盐酸达克罗宁 含量测定 

分 类 号：R927.2[医药卫生—药学]