硝酸咪康唑乳膏鉴别及含量测定方法的改进

目的改进硝酸咪康唑乳膏鉴别及含量测定的方法。方法分别考察了薄层色谱法、高效液相色谱法、改进的高效液相色谱法对硝酸咪康唑乳膏进行鉴别和含量测定。含量测定采用C18柱，流动相为0．5％醋酸铵溶液（用醋酸调节pH至3．5）-甲醇（20：80）；流速为1．0mL·min^-1；检测波长为220nm。采用外标法计算。结果改进的高效液相色谱法能准确的用于硝酸咪康唑的定性鉴别和含量测定。硝酸咪康唑在浓度0．05030～0．8043mg·min^-1。与峰面积呈良好的线性关系，回归方程为Y=5．249×10^7X-1．920×10^3，r=1．0000。平均回收率为99．57％，RSD为0．93％。结论改进的高效液相色谱法简单、灵敏、准确、可靠，能用于硝酸咪康唑的定性鉴别和含量测定。

Improvement in identification and determination of the content method for miconazole nitrate cream

Objective To improve the identification and the determination of the content method for miconazole nitrate cream. Methods Miconazole nitrate cream was identified by TLC, HPLC and improved-HPLC. Column C18 and the mobile phase was 0.5% acetate amine （adjusted to pH 3.5 with acetate acid） methanol ：20 ： 80, with flow rate 1.0 mL·min^-1 and the detective wavelength of 220 nm. Results Improved-HPLC method could identify and determine miconazole nitrate cream accurately. The linear range of the calibration curve of miconazole was 0. 050 30-0. 804 3 mg·min^-1（r=1. 000 0）, regression equation was Y= 5. 249 × 10^7X- 1. 920×10^3, and average recovery was 99.57%. The relative standard deviation （n=5） was 0.93%. Conclusion It can be used to identify and deterimine the content of miconazole nitrate. The method is simple, sensitive, accurate and reliable.