HPLC法测定盐酸二甲双胍片的含量及测量不确定度评定

Content determination of metformin hydrochloride tablets by HPLC and its evaluation of measurement uncertainty

目的:建立高效液相色谱法测定盐酸二甲双胍片含量及测量不确定度的评定方法。方法:采用高效液相色谱(HPLC)外标法,以Agilent ZORBAX Eclipse Plus C18(250mm×4.6mm,5μm)为色谱柱,磷酸盐缓冲溶液(pH3.5)-乙腈为流动相,检测波长为233nm,测定盐酸二甲双胍片含量,进行了完整的方法学验证,分析影响测量不确定度的主要因素,对各不确定度分量的数值进行评估。结果HPLC法测定盐酸二甲双胍片含量的扩展不确定度为1.3%,测量结果表示为(98.6±1.3)%,k=2。结论:HPLC法测定盐酸二甲双胍片含量,专属性强、准确度高、重现性好,为盐酸二甲双胍片的质量控制与测量不确定度评定提供参考。

HPLC external standard method was used for the content determination.The tests were performed on a column of Agilent ZORBAX Eclipse Plus C18(250 mm×4.6 mm,5μm)with buffer(pH3.5)and acetonitrile as the mobile phase.The determination wavelength was 233 nm.Uncertainty components were evaluated by establishing detected uncertainty calculation formula.The extended uncertainty was 1.3%and the determination result was expressed as(98.6±1.3)%,k=2.The method is good.