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醋酸氯己定溶液质量标准提升研究

         

摘要

Objective To improve the standard of the quality control of Chlorhexidine Acetate Solution. Methods A method to determine Chlorhexidine Acetate by HPLC was established. The chromatographic column was the Grace Smart Column(250 mm × 4. 6 mm,5 μm), filled with octadecysilane chemically bonded silca;the mobile phase was monopotassium phosphate 0. 02 mol/L ( 2. 7 g to 1 000 mL,pH 2. 5 ) -acetonitrile ( 65:35 );the detection wauelength 258 nm. Results Chlorhexidine Acetate showed excellent linearity, which were at the range of 10. 02~160. 31 μg/mL. The average recoveries was 102. 47%, RSD was 1. 60% ( n=9 ) . Conclusion The methods were simple, sensitive and with good reproducibility and could be used to control the quality of Chlorhexidine Acetate Solution.%目的 提高醋酸氯己定溶液的质量控制标准.方法 建立测定醋酸氯己定溶液中醋酸氯己定含量的高效液相色谱法(HPLC)法.色谱柱:Grace Smart柱(250 mm × 4. 6 mm,5μm),用十八烷基硅烷键合硅胶为填充剂;流动相:0. 02 mol/L磷酸二氢钾溶液(取磷酸二氢钾2. 7 g,加水溶解并定容至1 000 mL,用磷酸调pH至2. 5)-乙腈(65:35);检测波长:258 nm.结果 醋酸氯己定质量浓度在10. 02~160. 31μg/mL范围内与峰面积线性关系良好,回收率为102. 47%,RSD为1. 60%( n=9 ).结论 提高后的质量标准可行.

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