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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 method for the determination of the main drugs and related substances in irbesartan sustained-release capsules by RP-HPLC. Methods: The chromatographic column was Kromasil C18. The mobile phase consisted of acetonitrile-0.02mol·L-1 potassium dihydrogen phosphate (adjusted to pH = 2.60 with phosphoric acid) = 48:52, the detection wavelength was 245nm, the flow rate was 1mL · min- The column temperature was 30 ° C and the injection volume was 15 μL. Results: The linear range of irbesartan was 13.22 ~ 185.08μg · mL-1 (r = 0.9999). The average recovery was 99.86% and the RSD was 1.2%. Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.