摘要
目的:建立缬沙坦原料药及制剂中缬沙坦苄酯的含量测定方法。方法:采用反相高效液相色谱加校正因子的主成分自身对照法;色谱柱为C_(18)柱,流动相为水-乙腈(1:1)(用冰醋酸调节pH值至2.5),检测波长245 nm,流量为1.0 mL·min^(-1);测定缬沙坦和缬沙坦苄酯的标准曲线方程,以斜率计算缬沙坦苄酯相对缬沙坦的校正因子,用相对保留时间对缬沙坦苄酯进行定位。结果:缬沙坦苄酯的相对保留时间为5.4,相对校正因子为0.88;对13批样品中缬沙坦苄酯的含量进行测定,测得结果与对照品法测定结果一致。结论:该方法专属性强,灵敏度高,可准确有效地测定缬沙坦中缬沙坦苄酯的含量。
Objective： To establish a method for the determination of Valsartan Benzyl Ester in Valsartan raw materials and tablets. Methods： HPLC and Main component self-comparison with correction factor method were adopted. The determination was performed on a C18 column with water and acetonitrile （ 1： l ） （ adjusted pH to 2. 5 with acetic acid） as the mobile phase, the flow rate was 1.0 mL·min ^-1 and the detection wavelength was 245 nm. The linear equations of Valsartan and Valsartan Benzyl Ester were determined, slopes were used to calculate the relative correction factor of Valsartan Benzyl Ester to Valsartan and relative retention time was used to determine the position. Results： The relative retention time of Valsartan Benzyl Ester was 5.4 and the relative correction factor was 0. 88. 13 batches of samples were determined by relative correction factor method （RCFM） and standard curve method （SCM） , there were no differences in the results between the two methods. Conclusion： The method is specific and sensitive, it can be used for the quantitative analysis of Valsartan Benzyl Ester in Valsartan tablets and raw materials.
作者
邱少华
Qiu Shaohua(Linyi Institute for Food and Drug Control, Linyi 27600)
出处
《中国药品标准》
CAS
2016年第6期426-430,共5页
Drug Standards of China
关键词
缬沙坦
缬沙坦苄酯
相对校正因子
含量测定
Valsartan
Valsartan Benzyl Ester
relative correction factor
content determination
