醋酸倍他米松有关物质的HPLC法测定  

Determination of Related Substances of Betamethasone Acetate by HPLC

作　　者：狄会峰[1] 高莹[1] 吴海燕[1] 李伟华[1] 董传海[1] 

机构地区：[1]莱芜市人民医院,山东莱芜271000

出　　处：《中国医药工业杂志》2018年第2期219-223,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定醋酸倍他米松(1)原料药中的有关物质,以加校正因子的主成分自身对照法定量。采用Zorbax SB-C_(18)色谱柱,以乙腈∶水(35∶65)为流动相,检测波长254 nm,计算有关物质的相对校正因子(RCF),同时计算有关物质含量,并与标准曲线法测定结果比较,以验证方法的准确性。1有关物质倍他米松(2)、地塞米松(3)、醋酸地塞米松(4)、醋酸倍他米松环氧物(5)和倍他米松二乙酸酯(6)的相对保留时间分别为0.64、0.73、1.13、1.23和1.73,RCF分别为0.95、0.95、1.00、1.09和1.10。RCF法与标准曲线法测定结果没有显著性差异。1与各有关物质分离完全,均在0.1~10μg/ml范围内线性关系良好。各有关物质回收率为96.67%~99.68%,RSD为0.37%~0.83%。该方法简单易行,可准确测定1中的有关物质。An HPLC method was established for the determination of the related substances in betamethasone acetate （1） and the quantification was achieved by self-control method with correction factors. A Zorbax SB-C18 column was used, with the mobile phase of acetonitrile∶water （35∶65）, at the detection wavelength of 254 nm. The relative correction factors （RCFs） of the related substances were calculated with the slop of the linear equations so as to quantitatively determine the related substances. The results obtained by the proposed method were compared with those obtained by using the impurities reference standards to verify the method accuracy. As a result, the relative retention time of related substances were 0.64 （betamethasone, 2）, 0.73 （dexamethasone, 3）, 1.13 （dexamethasone acetate, 4）, 1.23 （betamethasone acetate epoxide, 5）, 1.73 （betamethasone-11,21-diacetate, 6）, with RCFs of 0.95, 0.95, 1.00, 1.09 and 1.10, respectively. The results showed that there was no significant difference between the results of RCF method and those of calibration curves method. In addition, 1 and its related substances were effectively separated. Their calibration curves were linear in the concentration range of 0.1—10 μg/ml. Their recoveries for the related substances were 96.67%—99.68%, with RSDs of 0.37%—0.83%. This method was simple, efficient and accurate for the quantitation of the related substances in betamethasone acetate.

关 键 词：醋酸倍他米松 有关物质 高效液相色谱 含量测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]