摘要
目的建立HPLC法同时测定康裂脂软膏中尿素和咪康唑的含量。方法采用Symmetry®C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1 mol·L^(-1)(1-)庚烷磺酸钠水溶液(离子对试剂)梯度洗脱,柱温为35℃,流速为1.0 mL·min^(-1),测定波长为205 nm。结果尿素和咪康唑皆在8.0~100.0 mg·L^(-1)内呈良好的线性关系,相关系数分别为0.999 1和0.999 5。结论本法操作简便,准确,重复性好,可用于康裂脂软膏的质量控制。
AIM To establish a method using HPLC coupled with UV detector for simultaneous determination of urea and miconazole in Kangliezhi ointment. METHODS The two compounds were separated on a Symmetry R C18 column (250 mm x 4. 6 mm, 5 |xm) and methanol -0.1 mol · L^-1 ( 1-) sodium heptane sulfonate was used as mobile phase with gradient. Colun temperature was set at 35 P , the flow rate was 1.0 Ml ·min^-1 and measurement wavelength was 205 nm. RESULTS The linear range for urea and miconazole was both 8.0 - 100. 0 mg· L^-1 , and the correlation coefficient was 0. 999 1 and 0.999 5 , respectively. CONCLUSION The method is simple, accurate, repeatable and suitable for quality control of Kangliezhi ointment.
作者
许琰
钟明康
李桂琼
王斌
王俐
高波
刘庆丰
李中东
XU Yan;ZHONG Mingkang;LI Guiqiong;WANG Bin;WANG Li;GAO Bo;LIU Qingfeng;LI Zhongdong(Department of Pharmacy, Huashan Hospital, Hehai University, Shanghai 200040 , China)
出处
《中国临床药学杂志》
CAS
2019年第2期126-129,共4页
Chinese Journal of Clinical Pharmacy