直接进样GC法测定喷昔洛韦乳膏中三氯叔丁醇含量  

Determination of Chlorobutanol in Penciclovir Cream by GC with Direct Injection

作　　者：杨海霞 李英杰 徐鑫 祝美华 

机构地区：[1]山东省药学科学院山东省生物药物重点实验室,济南250101 [2]山东明仁福瑞达制药股份有限公司山东省骨科疼痛类药物工程研究中心 [3]山东福瑞达医药集团公司山东省皮肤与黏膜给药工程技术研究中心

出　　处：《中国药师》2016年第12期2358-2360,共3页China Pharmacist

基　　金："重大新药创制"科技重大专项(编号:2009ZX09301-013)

摘　　要：目的:建立毛细管气相色谱法测定喷昔洛韦乳膏中三氯叔丁醇含量。方法:采用气相色谱法直接进样,进样体积为1μl;色谱柱为DB-624毛细管柱(30 m×0.32 mm,1.8μm);载气为氮气;流速为1.5 ml·min^(-1)。FID检测器,检测器温度为250℃;进样口温度为200℃,柱温采取程序升温:初始温度50℃,维持5 min,以30℃·min^(-1)升温至170℃,维持4 min。以乙腈为溶剂,采用内标法测定喷昔洛韦乳膏中三氯叔丁醇含量。结果:三氯叔丁醇在40.0~200.0μg·ml^(-1)浓度范围内线性关系良好(r=0.999 8),平均回收率为99.8%(RSD=0.6%,n=9)。结论:该法简便、重复性及准确性好,可用于喷昔洛韦乳膏中三氯叔丁醇含量测定。Objective： To establish a capillary GC method tor the determination of ehlorobutauol in penciclovir cream. Methods： A gas chromatography was used with the direct injection of 1 pd on a DB-624 capillary column （30 m×0.32mm, 1.8 μm） with an FID detector. The carrier gas was nitrogen at a flow rate of 1.5 ml·min^-1. The temperature of the injector was 200℃ and that of the FID was 250 ℃. The programmed column temperature was set as follows： maintained at 50 ℃ for 5 rain and then raised to 170 ~C at the rate of 30 ℃·min^-1 and mainlained for 4 min. Acetonitrile was used as the solvent. The am）unt of chlorobutanol in penciclovir cream was calculated by an internal standard method. Results ： The linear relationship of chlorobuianol was 40.0-200.0 μg ·min^-1 （ r = 0. 999 8 ）. The average recovery was 99.8% （ RSD = 0.6% , n = 9）. Conclusion： The method is simple, repeatable and aeeurate in the determination of chlorobutanol in penciclovir cream.

关 键 词：喷昔洛韦乳膏 三氯叔丁醇 气相色谱法 

分 类 号：R927.2[医药卫生—药学]