HPLC法测定硝酸咪康唑栓中硝酸咪康唑的含量

摘要

目的 建立硝酸咪康唑栓的HPLC含量测定方法.方法 采用HPLC法,色谱条件:ODS柱(250 mm×4.6 mm,5 μm);甲醇-乙腈-5 g·L-1醋酸铵溶液(42.5∶42.5∶15)为流动相;流速1.0 mL·min-1;检测波长230 nm;进样量10 μL;柱温35 ℃.结果 硝酸咪康唑进样量在0.499～2.994 mg·mL-1范围内,其峰面积值与进样质量浓度有良好的线性关系,r=0.999 1,回收率为100.7%,RSD为1.0%(n=3).结论 经与紫外-可见分光光度法比较,该法重复性好,灵敏度高,结果准确,适用于硝酸咪康唑栓的含量测定.%Objective To establish an HPLC method for Miconazole Nitrate Suppositories. Method Chromatography conditions were as follows:ODS column (250 mm × 4. 6 mm,5μm） ;methanol-acetonitrile-5 g o L-1 ammonium acetate solution (42. 5 : 42. 5 : 15) as mobile phasejflow rate of 1. 0 mL o min-1 ;detection wavelength of 230 nm;injection volume 10 μL;column temperature 35 ℃. Results Within the miconazole nitrate injection amount of 0. 499-2. 994 mg o mL-1 ,the peak area values and sample concentration showed a good linear relationship,r = 0. 999 1. The recovery was 100. 7% with RSD of 1. 0% (n = 3). Conclusion Compared with the UV-visible spectrophotometry,the method has good reproducibility and high sensitivity. The method is accurate, and is suitable for the determination of Miconazole Nitrate Suppository.