摘要
Abstract
Objective To prepare compound ketoconazole cream and establish a method for determining the content of com-pound ketoconazole cream.Methods A cream was made by combining ketoconazole with baicalin,and the optimal prescription conditions for compound ketoconazole cream were obtained by using design-response surface method.The content of ketoconazole and baicalin in the cream was determined by high performance liquid chromatography(HPLC).Results The optimal prescrip-tion conditions for the cream were determined as follows:1.41 g glycerol stearate,0.20 g sodium dodecyl sulfate and 1.34 g oc-tadecanol;the comprehensive evaluation of three batches of compound ketoconazole cream prepared under optimal prescription conditions were 95,96,and 96,respectively,similar to the predicted value of 95.737 points,which proved that the model was reliable.and 96.HPLC had good specificity for determining its content,and the linear equation for ketoconazole was A=17 265C+26 844,with a linear range from 25.00 μg/mL to 800.00 μg/mL;while the linear equation for baicalin was A=14392C-10 594,with a linear range from 27.50 μg/mL to 880.00 μg/mL.The recovery rate of the sample addition recovery test met the requirements.The intra-day precision RSD values of ketoconazole and baicalin were 0.74％and 0.28％(n=6),re-spectively,while the inter-day precision RSD values were 0.74％and 0.99％(n=5),respectively;and the RSD of the two re-peated experiments were 0.81％and 0.63％(n=5),respectively;and the test solution of compound ketoconazole cream re-mained stable within 24 hours after preparation.Conclusion The quality of compound ketoconazole cream prepared according to the optimal prescription meets the requirements,and the HPLC method for the content determination shows good repeatability and precision.What's more,the content determination results are accurate and highly specific.关键词
酮康唑/黄芩苷/乳膏制备/星点设计-响应面法/含量测定Key words
ketoconazole/baicalin/cream preparation/central composite design-response surface methodology/content de-termination分类
医药卫生
