HPLC测定米格列醇片的含量

Determination of the Content of Miglitol Tablets by HPLC

目的建立HPLC测定米格列醇片含量的方法。方法采用Zorbax TMS（250 mm×4.6 mm,5μm）色谱柱,磷酸盐缓冲液（取磷酸二氢钾1.36 g,1-癸烷磺酸钠2.62 g,加水至1 000 mL,振摇使溶解,用10%磷酸溶液或10%氢氧化钾溶液调节pH值至5.5）-乙腈（85∶1 5）为流动相,检测波长为210 nm。结果线性范围为20~500μg.mL？1（r=0.999 9,n=6）,平均回收率为100.8%,RSD=1.7%。结论本法用于测定米格列醇片的含量,结果准确灵敏,可获得满意的测定结果。

OBJECTIVE To establish an HPLC method for content determination of miglitol tablets.METHODS Zorbax TMS（250 mm×4.6 mm,5 ？m） column was used with a mobile phase of phosphate buffer solution（potassium dihydrogen orthophosphate 1.36 g and 1-decanesulfonic acid sodium salt 2.62 g dissolved in water and diluted to 1 000 mL,adjusted to pH 5.5 by 10% phosphoric acid or 10% potassium hydroxide）-acetonitrile（85∶15） and detection wavelength was set at 210 nm.RESULTS The calibration curve of content was linear in the range of 20 500 μg·mL 1（r=0.999 9,n=6）.The average recovery was 100.8% with RSD of 1.7%.CONCLUSION The method is simple,rapid,sensitive and accurate,and its result of determination is satisfactory.The method can be used for the determination of miglitol tablets.