摘要
目的建立一种多通道同时检测尿素乳膏制剂中尿素和氢化可的松含量的高效液相色谱-二极管阵列检测器方法,为尿素乳膏制剂的生产及质量控制提供依据。方法以90%乙腈-水为溶剂,通过超声提取,过滤,制备供试品。采用InertSustain AQ-C18(250 mm×4.6 mm,5μm)色谱柱,以磷酸水溶液为流动相A,乙腈为流动相B;梯度洗脱,流速为1.0 mL·min^(-1);柱温为35℃,检测波长在191 nm处测定尿素,在245 nm处测定氢化可的松。结果尿素在16.11~4028.32μg·mL^(-1)浓度范围内呈良好的线性关系,r=0.99556;平均回收率为98.3%(n=9,RSD=0.99%);氢化可的松在0.21~53.39μg·mL^(-1)浓度范围内呈良好的线性关系,r=0.99999;平均回收率为100.3%(n=9,RSD=1.26%)。结论本方法灵敏度高,分离效果好,耐用性强,适合批量分析,可为尿素乳膏的质量控制提供新手段。
OBJECTIVE To establish a HPLC-DAD(high performance liquid chromatography-diode array detector)method for the determination of hydrocortisone and urea in compound urea cream,in order to provide basis for the production and quality control of compound urea cream.METHODS Hydrocortisone and urea were extracted by acetonitrile-water(90∶10)with ultrasonic extraction,filtered.InertSustain AQ-C18(250 mm×4.6 mm,5μm)was used,with phosphoric acid solution(adjusted pH to 4.0 with phosphoric acid)as mobile phase A and acetonitrile as mobile phase B.Gradient elution was performed at a flow rate of 1.0 mL·min^(-1),column temperature was 35℃ and the detection wavelength was 191 nm for urea,245 nm for hydrocortisone.RESULTS The linearity of urea was fine in the range of 16.11-4028.32μg·mL^(-1)with the correlation coefficient of 0.99556.And the average recovery was 98.3%,with RSD being 0.99%.The linearity of hydrocortisone was fine in the range of 0.21-53.39μg·mL^(-1)with the correlation coefficient of 0.99999.And the average recovery was 100.3%,with RSD being 1.26%.CONCLUSION The new established HPLC-DAD method shows better sensitivity,convenience,and durability for the determination of the content in urea cream,and is suitable for batch analysis,which could be a new method for the quality control of urea cream.
作者
刘璇
舒文将
常嘉智
LIU Xuan;SHU Wen-jiang;CHANG Jia-zhi(Baoji Center for Food and Drug Control,Baoji 721013,China;Baoji Central Hospital,Baoji 721008,China)
出处
《海峡药学》
2025年第12期37-41,共5页
Strait Pharmaceutical Journal
