HPLC测定醋酸洗必泰溶液和滴鼻乳的含量  

Determination of the contents of chlorhexidine acetas solution and its nasal cream drop by HPLC

作　　者：董文玉[1] 孙效东[1] 马培琴[1] 石莉[1] 唐卫红 

机构地区：[1]解放军总医院药材处制剂室,北京100853

出　　处：《中国药学杂志》2000年第8期550-552,共3页Chinese Pharmaceutical Journal

摘　　要：目的　为醋酸洗必泰溶液和醋酸洗必泰滴鼻乳建立一种快速准确的分析方法。方法　采用HP10 5 0色谱系统 ,ZY110 4型C1 8柱 ,以磷酸盐缓冲液 ( 0 .0 2mol·L- 1 ,内含 0 .1%三乙胺 ,pH3 .5 ) 乙腈 ( 70∶30 )为流动相 ,甲磺酸酚妥拉明为内标 ,检测波长2 5 4nm。结果　醋酸洗必泰线性范围 40～ 2 0 0 μg·ml- 1 (r=0 .9992 ) ,最低检测浓度为 5 0ng·ml- 1 ,醋酸洗必泰滴鼻乳回收率为10 0 .38% ,精密度考查日内RSD≤ 1.86 % ,日间RSD≤ 3.2 1%。结论　本方法快速准确 ,重现性好 ,可作为醋酸洗必泰制剂的质量控制方法 。OBJECTIVE To establish a simple and accurate method for the RP-HPLC determination of chlorhexidine acetas in its solutions and nasal drop.METHODS Hewlett Packard Series 1050 HPLC system and ZY1104 C 18 column was used with mobile phase: phosphate buffer (0.02 mol·L -1 , 0.1% triethylamine, pH3.5)acetonitrile (70∶30); phentolamine mesylate was used as the internal standard;The detection wavelength was at 254nm. RESULTS: Chlorhexidine acetas over the range of 40～200 μg·ml -1 had a good linear coefficient(r= 0.9992 ). The lowest detectable concentration was 50 ng·ml -1 . The recovery of chlorhexidine acetas nasal drop was 100.38%. The average coefficient variation of withinrun and betweenrun was less than 3.5%.CONCLUSION It is an important method for the quality control of pharmaceutical products of chlorhexidine acetas and their stability.

关 键 词：高效液相色谱法 醋酸洗必泰 溶液 滴鼻乳 

分 类 号：R927.2[医药卫生—药学] R987