RP-HPLC法测定厄贝沙坦缓释胶囊中主药及有关物质的含量

Content Determination of Main Components and Related Substances in Irbesartan Sustained-release Capsules by RP-HPLC

目的:建立以反相高效液相色谱法测定厄贝沙坦缓释胶囊中主药及有关物质含量的方法。方法:色谱柱为Kromasil C18,流动相为乙腈-0.02mol·L-1磷酸二氢钾水溶液(用磷酸调节pH至2.60)=48∶52,检测波长为245nm,流速为1mL·min-1,柱温为30℃,进样量为15μL。结果:厄贝沙坦检测浓度的线性范围为13.22～185.08μg·mL-1(r=0.9999);平均回收率为99.86%,RSD=1.2%。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。

OBJECTIVE： To establish a RP- HPLC method for the determination of main components and its related substances in irbesartan sustained - release capsules（ ISRC）. METHODS： RP - HPLC was performed on a Kromasil C18 column using acetonitrile - 0.02 mol·L^-1 KH2PO4 （48 ： 52, pH = 2.60, adjusted by H3PO4 solution） as the mobile phase at a flow rate of 1 mL·min^-1. The detection wavelength was set at 245 nm. The column temperature was 30℃ and the sample size was 15uL. RESULTS： The linear range of irbesartan was 13.22--185.08ug·mL^-1 （r = 0.999 9）, and the average recovery was 99.86%, RSD - 1.2%. CONCLUSION： The method is simple, accurate, and specific and can be used for the quality control of ISRC.