HPLC测定米格列醇片的含量

Determination of the Content of Miglitol Tablets by HPLC

摘要: 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，5 μm)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∶15)为流动相，检测波长为210 nm。结果线性范围为20~500 μg·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。

Abstract: OBJECTIVE To establish an HPLC method for content determination of miglitol tablets. METHODS Zorbax TMS(250 mm×4.6 mm, 5 μm) 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.