摘要
目的建立测定复方咪康唑洗剂中硝酸咪康唑含量的高效液相色谱法。方法色谱柱为Eclipse XDB C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.5%乙酸铵溶液(20∶80),流速为1.0 m L/min,检测波长为235 nm,柱温为30℃。结果硝酸咪康唑质量浓度在0~2.106 0 g/L范围内与峰面积呈良好的线性关系(r=0.999 3),平均回收率为98.98%,RSD=1.91%(n=9)。结论该法简便快速、准确、重复性好,可用于该制剂中硝酸咪康唑的含量测定。
Objective To establish an HPLC method to determine miconazole nitrate in compound miconazole nitrate lotion. Methods The analysis was carried out at 30 ℃ on a Eclipse C18 column( 250 mm × 4. 6 mm,5 μm). The mobile phase consisted of methanol-0. 5% ammonium acetate solution( 20:80) with the flow rate of 1. 0 m L / min. The detection wavelength was 235 nm. The column temperature was 30 ℃. Results The calibration curve of miconazole nitrate was linear over the range of 0- 2. 106 0 g / L( r = 0. 999 3). The average recovery was 98. 98%( RSD = 1. 91%, n = 9). Conclusion This method is simple, accurate, reproducible and applicable for the content determination of miconazole nitrate in Compound Miconazole Nitrate Lotion.
出处
《中国药业》
CAS
2016年第7期46-48,共3页
China Pharmaceuticals