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作 者:任翠丽 尹情胜 俞敏[2] 徐文佳[2] 王小董[2] 王世亮[2]
机构地区:[1]安徽中人科技有限责任公司,安徽合肥230061 [2]合肥工业大学控释药物研究室,安徽合肥230009
出 处:《安徽医药》2013年第8期1294-1295,共2页Anhui Medical and Pharmaceutical Journal
基 金:安徽省科技攻关计划项目(No 07020303069)
摘 要:目的建立地塞米松植入剂含量测定方法并进行方法学验证。方法采用HPLC法,色谱柱为ODS-C18柱,以乙腈—水(32∶68,V/V)为流动相,检测波长为240 nm。结果方法的专属性较好,辅料不干扰测定;地塞米松在20.23~80.92 mg·L-1范围内线性关系良好(r=1.00);低、中、高3种浓度的平均回收率为100.10%,RSD为1.08%,日间精密度RSD为0.60%,在室温下供试品溶液可稳定8 h。结论该方法简便、准确、重现性好,可用于地塞米松植入剂的含量测定。Objective To establish a method for the determination of dexamethasone implants.Methods HPLC analysis was carried out with C18 column and acetonitrile-water(32:68) as mobile phase.The detection wavelength was 240 nm.Results The specificity of the determination is relatively good.Excipient didn’t interfere with the determination.The calibration curve was linear(r = 1.00) in the range of 20.23 ~ 80.92 mg.L-1.The average recovery was 100.10%.RSD was 1.08%.Between-run precision was 0.60%.The sample solution was steady within 8 h at room temperature.Conclusion The method is simple,accurate and reliable with the good reproducibility and can be used for the determination of dexamethasone implants.
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