高效液相色谱双波长法同时测定复方枇杷喷托维林颗粒中三种成分

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目的 建立高效液相色谱(HPLC)双波长法同时分离测定复方枇杷喷托维林颗粒中的枸橼酸喷托维林、甘草酸和甘草次酸,为药物质量标准的提高提供理论依据.方法 本研究于2019年6月至2020年5月在西安市食品药品检验所化学实验室进行.采用热电C18色谱柱(250 mm×4.6 mm,5μm),甲醇–1%三乙胺水溶液(磷酸调节pH为3.0)二元梯度洗脱,流速1.0 mL/min,进样量10μL,检测波长215 nm和250 nm.结果 三种组分分别在10.24~511.97μg/mL、4.89~244.74μg/mL和0.50~25.12μg/mL浓度范围内线性关系良好,枸橼酸喷托维林、甘草酸和甘草次酸的平均回收率分别为102.27%,99.94%和98.02%,相应的RSD为2.31%~2.42%.结论 本法简便、准确,灵敏度高,可用于复方枇杷喷托维林颗粒的质量控制.
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