高效液相色谱法测定地塞米松植入剂的有关物质  

An HPLC method for determination of related substances of dexamethasone implants

作　　者：任翠丽[1,2] 夏伦洋 尹情胜[1,2] 王世亮[1,2,3] 吴永贵[4] 周春霞[1,2] 

机构地区：[1]合肥工业大学控释药物研究室 [2]安徽中人科技有限责任公司 [3]安徽四维药业有限公司,安徽合肥230009 [4]安徽医科大学第一附属医院肾内科,安徽合肥230022

出　　处：《安徽医药》2015年第4期665-668,共4页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省教育厅自然科学基金重大项目资助(No KJ2010ZD06)

摘　　要：目的：建立高效液相色谱测定地塞米松植入剂有关物质的方法。方法采用天津兰博Kromasil-C18柱（250 mm × 4．6 mm，5μm），流动相为乙腈—水（28∶72，V／V），流速为2．0 mL· min^－1，检测波长为240 nm，柱温：35℃。结果地塞米松与有关物质分离良好，辅料不干扰测定；地塞米松、倍他米松在0．1-10 mg· L^－1范围内线性关系良好；倍他米松低、中、高3种浓度的加样平均回收率为：98．23％，RSD为：0．61％，地塞米松与倍他米松的定量限、检测限依次为：1．17、1．04、0．39、0．34μg· L^－1。在室温下供试品溶液可稳定8h。结论该方法操作简便准确、灵敏度高，适用于地塞米松植入剂有关物质检查。Objective To establish an HPLC method for the determination of related substances of dexamethasone implants.Methods A Kromasil-C18 column（250 mm × 4.6 mm,5 μm）was adopted with a mobile phase of a mixture of acethane-water （ 28∶72） at a flow rate of 2.0 mL· min^-1 and UV detector wavelength at 240 nm.The column tempreture was 35℃.Results Dexamethasone and relat-ed substances could be baseline separated,and the excipients didn’ t interfere with the determination.The linear ranges of dexametha-sone and betamethasone were both 0.1-10 mg· L ^-1 .The average recoveries at low,middle and high concentration of betamethasone were all 98.23%.RSD was 0.61%.The LOQ,LOD of dexamethasone and betamethasone were 1.17,1.04 ,0.39 ,and 0.34 μg· L^-1 respectively, The sample solution was steady within 8 h at room temperature.Conclusion This method is rapid,accurate and sensi-tive,which can be used for determination of the content and related substances of dexamethasone implants.

关 键 词：地塞米松植入剂 高效液相色谱法 有关物质 

分 类 号：R927.1[医药卫生—药学] O657.72[理学—分析化学]