摘要
目的:建立测定胆维丁原料药及其有关物质含量的方法。方法:采用高效液相色谱法,参照《中国药典》2010年版二部中维生素D3和胆固醇的含量测定项下方法测定胆维丁中2种成分的含量,其中胆固醇测定时由《中国药典》的蒸发光散射检测器改为二极管阵列检测器,并进行方法学考察。维生素D3和有关物质含量测定的色谱柱为PhenomenexLuna5μmSilica(2),流动相为正己烷-正戊醇(997:3),测定波长为254nm,流速为2·5mL·min-1;胆固醇测定的色谱柱为WatersSunfireC18,流动相为甲醇,检测波长205nm,流速为1·0mL·min-1。结果:胆固醇检测浓度线性范围为51·15～511·5μg·mL-1(r=0·9999),平均回收率为98·75%(RSD=0·94%)。结论:建立的方法准确、可靠,能有效控制胆维丁原料药的质量。
OBJECTIVE：To establish a method for the content determination of cholecalciferol cholesterol and related substances.METHODS：HPLC method was adopted to determine the contents of cholecalciferol cholesterol and related substances,referring to the determination method of vitamin D3 and cholesterol stated in Chinese Pharmacopeia（2010 edition）.UV detector replaced ELSD detector for the determination of cholesterol stated in Chinese Pharmacopeia.Phenomenex Luna 5 μm Silica（2） was used for the content determination of vitamin D3 and related substances,the mobile phase was hexanes-pentanol（997：3） at a flow rate of 2.5 mL·min-1 and the detection wavelength was set at 254 nm.Waters Sunfire C18 column was used for the determination of cholesterol,the mobile phase was menthol at a flow rate of 1.0 mL·min-1 and detection wavelength was set at 205 nm.RESULTS：The linear range of cholesterol was 51.15～511.5 μg·mL-1（r=0.999 9） with an average recovery of 98.75%（RSD=0.94%）.CONCLUSION：The method is accurate,reliable and suitable for the quality control of cholecalciferol cholesterol.
出处
《中国药房》
CAS
CSCD
2012年第21期1999-2002,共4页
China Pharmacy
作者简介
何丹,讲师,硕士。研究方向:药物分析。电话:023-68485048。E-mail:ildoctor@163.com
