论文部分内容阅读
目的:建立梯度洗脱HPLC法测定硝酸益康唑的有关物质。方法:采用Thermo Hypersil BDS C18(100mm×4.6mm,3μm)色谱柱,以甲醇-0.077%醋酸铵溶液(20:80)为流动相A,甲醇-乙腈(40:60)为流动相B,梯度洗脱,流速0.9mL.min-1,检测波长225nm,柱温35℃。结果:硝酸益康唑浓度在4.03～50.35μg.mL-1范围内,与峰面积呈良好的线性关系,r=0.9999。结论:本法简便、准确,可定量测定硝酸益康唑的有关物质。
Objective: To establish a gradient elution HPLC method for the determination of econazole nitrate related substances. METHODS: The mobile phase A was consisted of methanol-acetonitrile (40:60) and mobile phase B using a gradient of methanol-acetonitrile (40:60) with methanol-0.077% ammonium acetate solution (20:80) on a Thermo Hypersil BDS C18 (100 mm × 4.6 mm, Elution, flow rate 0.9mL.min-1, detection wavelength 225nm, column temperature 35 ℃. Results: Econazole nitrate concentration in the range of 4.03 ~ 50.35μg.mL-1, and the peak area showed a good linear relationship, r = 0.9999. Conclusion: This method is simple, accurate, quantitative determination of econazole nitrate related substances.