加校正因子的主成分自身对照法测定赖诺普利氢氯噻嗪片中有关物质的含量

HPLC Method with Correction Factor for Determination of Content of the Related Substances in Lisinopril and Hydrochlorothiazide Tablets

目的:建立加校正因子的主成分自身对照法测定赖诺普利氢氯噻嗪片中有关物质的含量。方法:Ultimate XBC18色谱柱(4.6 mm×250 mm,5μm),流动相0.05 mol·L-1磷酸盐缓冲溶液(pH7.3±0.1)-乙腈(85∶15),流速1.0 mL·min-1,检测波长210 nm,柱温30℃,进样量10μL。测定赖诺普利及其杂质赖诺普利相关物质A,氢氯噻嗪及其杂质苯并噻二嗪相关物质A的线性方程,以斜率计算杂质相对于主成分的校正因子,用相对保留时间确定各杂质位置。其他有关物质的含量采用自身对照法计算。结果:赖诺普利相关物质A和苯并噻二嗪相关物质A的相对保留时间分别为1.88,0.69,校正因子分别为1.16,0.87。3批样品中苯并噻二嗪相关物质A的质量分数分别为0.671%,0.673%,0.660%,其他杂质均低于检测限。结论:该方法简便快速,可准确测定赖诺普利氢氯噻嗪片中有关物质的含量。

Objective：The self contrast and correction factor method was established to determine the content of the related substances in lisinopril and hydrochlorothiazide tablets.Method：Chromatography was carried out by reversed-phase technique to a Ultimate XB-C18 （4.6 mm × 250 mm,5 μm） with a mobile phase composed of 0.05 mol ·L^-1 phosphate buffer （pH 7.3 ± 0.1）-acetonitrile （85∶15） pumped at a flow-rate of 1.0 mL ·min^-1 The detection was carried out at a wavelength of 210 nm and a column temperature of 30 ℃.The injection volume was l0 μL.The slope of linear equation was used to determine the correction factor of lisinopril related compound A and benzothiadiazine related compound A.Result：The relative retention times of lisinopril related compound A and benzothiadiazine related compound A were 1.88 and 0.69,respectively.The correction factors of lisinopril related compound A and benzothiadiazine related compound A were 1.16 and 0.87,respectively.The contentsof benzothiadiazine related compound A from three batches of samples were 0.671%,0.673% and 0.660%.Other impurities weren＇t detected.Conclusion：The method was simple,efficient and accurate for analyzing the related substances in lisinopril and hydrochlorothiazide tablets.