高效液相色谱法测定曲咪新乳膏中硝酸咪康唑有关物质

Determination of related substances of miconazole nitrate in triamcinolone acetonide acetate and miconazole nitrate neomycin sulfate cream by HPLC

目的建立高效液相色谱法测定曲咪新乳膏中硝酸咪康唑有关物质。方法使用YMCTriart C18柱(150 mm×4.6 mm,5μm);以甲醇-0.05%醋酸铵溶液为流动相,梯度洗脱;柱温30℃、检测波长230 nm、流速1.0 mL·min^(-1)。对硝酸咪康唑杂质A(降解杂质)进行定量分析,其他杂质作限度检查。结果系统适用性试验中,硝酸咪康唑6个杂质峰均完全分离,制剂中的主成分和辅料对有关物质测定无干扰。杂质A的平均回收率在89.99%~100.19%(RSD<4.1%),硝酸咪康唑的平均回收率在91.50%~103.02%(RSD<6.9%)。结论所建立的方法重复性好、专属性强,可用于曲咪新乳膏中硝酸咪康唑有关物质的检查。

Objective To determine the related substances of miconazole nitrate in triamcinolone acetonide acetate and miconazole nitrate neomycin sulfate cream by HPLC.Methods YMCTriart C18 column(150 mm×4.6 mm,5μm)was used.Gradient elution was conducted with methanol-0.05%ammonium acetate solution as the mobile phase.The column temperature was 30℃,the detection wavelength was 230 nm,and the flow rate was 1.0 mL·min^(-1).Miconazole nitrate impurity A(degradation impurity)was quantitatively controlled and other impurities were checked for limits.Results In the system applicability test,six impurity peaks of miconazole nitrate were well separated,and the main components and excipients in the preparation did not interfere with the determination of related substances.The average recovery of impurity A was 89.99%~100.19%(RSD<4.1%),and the average recovery of miconazole nitrate was 91.50%~103.02%(RSD<6.9%).Conclusion The method has good repeatability and strong specificity,and it is suitable for the determination of related substances of miconazole nitrate in triamcinolone acetonide acetate and miconazole nitrate neomycin sulfate cream.