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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 ,更适合洗必泰制剂在贮存和使用过程中的稳定性考察
The purpose of chlorhexidine acetate solution and chlorhexidine acetate nasal drops to establish a rapid and accurate method of analysis. Methods HPLC was carried out on a HP10 50 chromatography system and a ZY110 4 C1 8 column using phosphate buffer (0. 2 mol·L -1, containing 0.1% triethylamine, pH 3.5) As mobile phase, phentolamine mesylate as internal standard, detection wavelength of 254nm. Results The linear range of chlorhexidine acetate was 40 ~ 200 μg · ml-1 (r = 0.9992), the lowest detection concentration was 50 ng · ml-1, and the recovery rate of chlorhexidine acetate drops was 0.38 %, RSD ≤ 1.86% of the precision test day, RSD ≤ 3.2 1% during the day. Conclusion The method is rapid, accurate and reproducible. It can be used as a quality control method of chlorhexidine acetate and is more suitable for the stability of chlorhexidine preparations during storage and use