中空纤维分离-高效液相色谱法测定复方痤疮凝胶中主药的含量  

Separation and Determination of Clindamycin Phosphate and Tretinoin in Acne Gel by Hollow Fiber-High Performance Liquid Chromatography

作　　者：马亚中[1] 吴燕[1] 刘丽平[1] 林向阳[2] 

机构地区：[1]空军总医院药学部,北京100142 [2]解放军空军后勤部卫生部,北京100720

出　　处：《医药导报》2011年第10期1340-1343,共4页Herald of Medicine

摘　　要：目的建立中空纤维分离-高效液相色谱(HPLC)法测定复方痤疮凝胶剂中主药含量的方法。方法采用中空纤维处理凝胶样品,含量测定以Venusil XBP-C18色谱柱(4.6 mm×150 mm,5μm)为固定相,以磷酸盐缓冲液(取0.015 mol.L-1磷酸二氢钾溶液,磷酸溶液调节pH至3.0)-乙腈为流动相进行梯度洗脱;进样量:20μL;柱温:30℃;流速:1.0 mL.min-1;紫外检测波长:克林霉素磷酸酯:210 nm,维A酸:350 nm。结果主成分峰与相邻杂质峰分离度>1.5。克林霉素磷酸酯在48.00～480.00μg.mL-1范围内线性关系良好,r=0.999 8,平均回收率为99.96%,RSD为0.69%(n=6),维A酸在1.00～20.00μg.mL-1范围内线性关系良好,r=0.999 7,平均回收率为99.99%,RSD为1.24%(n=6)。结论该方法简单、可靠,可用于复方痤疮凝胶剂中的样品处理和含量测定。Objective A simple sample pretreatment method was developed for the determination of clindamycin phosphate and tretinoin in Acne Gel by hollow fiber-HPLC. Methods The gel sample pretreatment was carried out by hollow fiber.The chromatographic analysis was carried out on a Venusil XBP-C18 column（150 mm×4.6 mm,5 μm）with acetonitrile and potassium dihydrogen phosphate buffer solution（the pH value was adjusted to 3.0 by phosphoric acid）as the mobile phase by gradient elution at a flow rate of 1.0 mL·min-1.The column temperature was 30 ℃ and sample size was 20 μL.The detection wavelength of clindamycin phosphate and tretinoin in Acne Gel were set at 210 nm and 350 nm,respectively. Results The good resolution between peaks of main drugs and of the adjacent purity was obtained.Good linear relations in determination of clindamycin phosphate and tretinoin were obtained in the range of 48.00-480.00 μg·mL-1（r= 0.999 8） and 1.00-20.00 μg·mL-1（r=0.999 7）,respectively.Meanwhile,the average recovery were 99.96%（RSD=0.69%,n=6）and 99.99%（RSD=1.24%,n=6）. Conclusion This method is simple and accurate,and it＇s suitable for the sample pretreatment and content determination of mian drugs in acne gel.

关 键 词：痤疮凝胶 中空纤维 含量测定 色谱法 高效液相 卡波姆 

分 类 号：R986[医药卫生—药品] R927.2[医药卫生—药学]