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目的:建立以高效液相色谱法测定复方罗格列酮盐酸二甲双胍片中罗格列酮含量的方法。方法:色谱柱为Phenomenex Ods3-C18,流动相为0.38%醋酸铵溶液-乙腈(50∶50),检测波长为247nm,流速为1.0mL·min-1,进样量为20μL。结果:罗格列酮检测浓度的线性范围为20.40～183.60μg·mL-1(r=0.999 9);平均回收率为99.5%,RSD=0.82%(n=5)。结论:本方法操作简便、准确,可用于该制剂中罗格列酮的含量测定。
Objective: To establish a method for the determination of rosiglitazone in compound rosiglitazone hydrochloride metformin hydrochloride tablets by high performance liquid chromatography. Methods: The chromatographic column was Phenomenex Ods3-C18 with a mobile phase of 0.38% ammonium acetate solution (50:50). The detection wavelength was 247 nm and the flow rate was 1.0 mL · min-1. The injection volume was 20 μL. Results: The linear range of rosiglitazone was 20.40 ~ 183.60μg · mL-1 (r = 0.999 9). The average recovery was 99.5% with RSD 0.82% (n = 5). Conclusion: The method is simple, accurate and can be used for the determination of rosiglitazone in this preparation.