HPLC法测定双唑乳膏中克霉唑与硝酸益康唑的含量

目的：建立高效液相色谱法测定双唑乳膏中克霉唑与硝酸益康唑的含量.方法：采用高效液相色谱法,色谱柱为Alltech Alltima C18色谱柱（150 mm×4.6 mm,5 μm）,流动相为磷酸盐缓冲液（取磷酸二氢钾与磷酸氢二钾各2.5 g,加水溶解并稀释至1000 ml）-甲醇（25∶75）,流速为1.0 ml/min,柱温为35 ℃,检测波长为232 nm.结果：克霉唑与硝酸益康唑在0.25~100 μg/ml范围内,浓度与其峰面积呈良好线性关系（r=0.9999,n=9）,平均回收率分别为99.87%与101.11%,RSD%分别为1.4%与1.8%.结论：为双唑乳膏中克霉唑与硝酸益康唑联合用药的新剂型建立了简单、快速、专属性强、重现性好的含量测定方法,可用于双唑乳膏中克霉唑与硝酸益康唑的测定.

Determination of clotrimazole and econazole nitrate in clotrimazole and econazole nitrate cream by HPLC

Objective： Establish an RP - HPLC method for determination of clotrimazole and eeonazole nitrate in clotrimazole and econazole nitrate cream. Methods： Apply HPLC on Alhech Alhima Cls column（ 150 mm×4.6 mm,5 μm）, take phosphate buffer solution（ dissolve 2.5 g of dipotassium hydrogen phosphate and 2.5g of potassium dihydrogen phosphate in 1L water） - methanol（ 25：75 ） as mobile phase, the flow rate was 1.0 ml/min, The column temperature was 35 ℃ ; the detection wavelength was 232 nm. Results： The linear range of clotrimazole and econazole nitrate was 0.25 - 100 μg/ml（ r =0. 9999,n =9） , the aver- age recovery rate was 99.87% （ RSD% was 1.4% ） and 101.11% （ RSD% was 1.8% ） , hmit of detection was 50 ng/ml and limit of quantitation was 0.25 μg/ml. Conclusion： Established an RP - HPLC method for determination of clotrimazole and econ- azole nitrate in clotrimazole and econazole nitrate cream, which is simple, speedy and highly effective with good specificity and re- producibility.