HPLC法测定坎地沙坦酯片中有关物质  

Determination of related substances in Candesartan Cilexetil Tablets

作　　者：房思萌[1] 苏慕君[1] 臧可昕[1] 

机构地区：[1]天津药物研究院,天津300193

出　　处：《现代药物与临床》2014年第7期729-733,共5页Drugs & Clinic

摘　　要：目的分析对比多国药典改进HPLC法测定坎地沙坦酯及其片剂中有关物质的方法。方法采用HPLC法对坎地沙坦酯及其片剂中9个杂质进行测定。Waters Symmetry C18色谱柱(150 mm×4.6 mm,5μm);流动相:[乙腈–水–冰醋酸(57∶43∶1)]–[乙腈–水–冰醋酸(90∶10∶1)],梯度洗脱;体积流量:0.9 mL/min;柱温:35℃;样品仓温度:10℃;进样量:20μL;检测波长:254 nm。结果在选定的色谱条件下,坎地沙坦酯与有关物质分离良好。试验专属性、线性、耐用性良好。结论本研究可为坎地沙坦酯片的质量标准的制订和提高提供参考和依据。Objective To optimize the HPLC method to determinate the related substances in candesartan cilexetil and its tablets compared with the national pharmacopoeias.Methods Nine impurities in Candesartan Cilexetil Tablets were separated and identified by HPLC. Chromatographic separation was carried out on an Waters Symmetry C18 column （150 mm x 4.6 mm, 5μm） at a flow rate of 0.9 mL/min. [Acetonitrile - water - acetic acid glacial （57∶43∶1）]-[acetonitrile - water - acetic acid glacial （90∶10∶1）] was used as mobile phase. It was monitored at a wavelength of 254 nm, the temperatures of column and sample chamber were 35 and 10℃, and the injection volume was 20μL..Results There was good separation among candesartan cilexetil and related substances under the chromatographic conditions. The method had good specificity, linearity, and durability.Conclusion It provides reference and basis to develop and improve the quality control of Candesartan Cilexetil Tablets.

关 键 词：坎地沙坦酯片 坎地沙坦酯 有关物质 高效液相色谱 

分 类 号：R927.11[医药卫生—药学]