HPLC法同时测定康裂脂软膏中尿素和咪康唑的含量
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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■ C_(18) column(250 mm×4.6 mm,5μm)and methanol-0.1 mol·L~(-1)(1-)sodium heptane sulfonate was used as mobile phase with gradient.Colun temperature was set at 35℃,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 8.0-100.0mg·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.
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■ C_(18) column(250 mm×4.6 mm,5μm)and methanol-0.1 mol·L~(-1)(1-)sodium heptane sulfonate was used as mobile phase with gradient.Colun temperature was set at 35℃,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 8.0-100.0mg·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.
引文
[1] 陈芳,常明泉,王刚,等.分光光度法测定复方白及乳膏中尿素的含量[J].儿科药学杂志,2012,18(6):45.
[2] 谢向阳,李银科,李旸,等.HPLC法测定尿素软膏中尿素的含量[J].中国药师,2012,15(9):1279.
[3] 刘卿,宋书锋.高效液相色谱-荧光检测器法测定面粉中的尿素[J].中国卫生检验杂志,2016,26(9):1232.
[4] 郭旭光,郑子栋,郭海波.HPLC法测定曲安奈德益康唑乳膏中的有关物质[J].中国药房,2014,25(4):1134.
[5] 黄文涛,程璐.HPLC法同时测定复方酮康唑凝胶中酮康唑、硝酸咪康唑的含量[J].中国药师,2014,17(2):310.
[2] 谢向阳,李银科,李旸,等.HPLC法测定尿素软膏中尿素的含量[J].中国药师,2012,15(9):1279.
[3] 刘卿,宋书锋.高效液相色谱-荧光检测器法测定面粉中的尿素[J].中国卫生检验杂志,2016,26(9):1232.
[4] 郭旭光,郑子栋,郭海波.HPLC法测定曲安奈德益康唑乳膏中的有关物质[J].中国药房,2014,25(4):1134.
[5] 黄文涛,程璐.HPLC法同时测定复方酮康唑凝胶中酮康唑、硝酸咪康唑的含量[J].中国药师,2014,17(2):310.