HPLC测定醋酸洗必泰溶液和滴鼻乳的含量

 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HP1050色谱系统，ZY1104型C₁₈柱，以磷酸盐缓冲液（0.02 mol·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254 nm。结果 醋酸洗必泰线性范围40～200 μg·ml^-1（r=0.9992），最低检测浓度为50 ng·ml^-1，醋酸洗必泰滴鼻乳回收率为100.38%，精密度考查日内RSD≤1.86%，日间RSD≤3.21%。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。

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

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 C₁₈column 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 within-run and between-run was less than 3.5%.CONCLUSION It is an important method for the quality control of pharmaceutical products of chlorhexidine acetas and their stability.