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目的:用反相高效液相色谱法测定利培酮片含量。方法:以美国Dikma公司DiamonsilTMC18反相柱(250mm×4.6mm,5μm)为色谱柱,流动相为甲醇-超纯水(90:10),流速为0.8mL/min,检测波长为280nm,柱温为30℃,进样量为5μL。结果:利培酮与片剂辅料及杂质可完全分离;分析方法的定量测定下限为0.1μg/mL,线性范围为1.0～100.0μg/mL,回归方程为Y=1.08×10-1X-3.02×10-1,r=0.9996(n=6),平均回收率为99.5%,RSD=0.36%。结论:方法灵敏、准确、简单、快速,可用于利培酮片的含量测定。
Objective: To determine the content of risperidone tablets by reversed-phase high performance liquid chromatography. Methods: The Diamonsil TMC18 reversed-phase column (250 mm × 4.6 mm, 5 μm) from Dikma Company of America was used as the mobile phase. The mobile phase consisted of methanol and ultrapure water (90:10), the flow rate was 0.8 mL / min, the detection wavelength was 280 nm, 30 ℃, the injection volume of 5μL. Results: Risperidone could be completely separated from tablet excipients and impurities. The lower limit of quantitation was 0.1μg / mL, the linear range was 1.0-100.0μg / mL, the regression equation was Y = 1.08 × 10-1X-3.02 × 10-1, r = 0.9996 (n = 6), with an average recovery of 99.5% and RSD = 0.36%. Conclusion: The method is sensitive, accurate, simple and rapid and can be used for the determination of risperidone tablets.