HPLC法同时测定复方达克罗宁含漱液中主要成分的含量

目的: 建立高效液相色谱法同时测定复方达克罗宁含漱液中葡萄糖酸氯己定、盐酸达克罗宁和氢化可的松的含量。 方法: 采用Waters Symmetry C₁₈(250 mm×4.6 mm,5 μm)色谱柱,流动相为0.015 mol·L^-1醋酸铵溶液(含0.1%三乙胺和2%醋酸)-甲醇(40∶60),流速0.6 mL·min^-1,柱温35 ℃,检测波长254 nm。 结果: 葡萄糖酸氯己定、盐酸达克罗宁和氢化可的松的线性范围分别为8.42~168 mg·L^-1(r=0.9995),11.2~224 mg·L^-1(r=0.9995),4.03~80.7 mg·L^-1(r=0.9995);平均加样回收率分别为100.0%,100.5%,101.7%;RSD分别为1.5%,2.0%,1.0%(n=9)。 结论: 该方法简便准确,可用于复方达克罗宁含漱液的质量控制。

Objective: To establish an HPLC method for the simultaneous determination of chlorhexidine gluconate,dyclonine hydrochloride and hydrocortisone in compound dyclonine gargle. Methods: The chromatographic separation was performed on a Waters Symmetry C₁₈ column with a mixture of 0.015 mol·L^-1 ammonium acetate solution(adding 0.1% triethylamine and 2% acetic acid to the total volume of solution)-methanol(40∶60) as mobile phase at the flow rate of 0.6 mL·min^-1,the column temperature was maintained at 35 ℃ and the detection wavelength was 254 nm. Results: The calibration curves in the range of 8.42-168 mg·L^-1(r=0.9995) for chlorhexidine gluconate,11.2-224 mg·L^-1(r=0.9995)for dyclonine hydrochloride and 4.03-80.7 mg·L^-1(r=0.9995) for hydrocortisone were good linear,respectively.The average recoveries were 100.0%,100.5% and 101.7%;RSD were 1.5%,2.0% and 1.0%(n=9). Conclusion: An accurate method can be used for the quality control of Compound dyclonine gargle.

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