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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 a HPLC method for the determination of miglitol tablets. Methods Zorbax TMS (250 mm × 4.6 mm, 5 μm) column was used. Phosphate buffer (1.36 g monobasic potassium phosphate and 2.62 g sodium 1-decanesulfonate) was added to 1 000 mL water and shaken to dissolve. The pH was adjusted to 5.5 with 10% phosphoric acid solution or 10% potassium hydroxide solution - acetonitrile (85: 1 5) as the mobile phase and the detection wavelength was 210 nm. The linear range was 20 ~ 500μg.mL? 1 (r = 0.999 9, n = 6). The average recovery was 100.8% and RSD was 1.7%. Conclusion This method is used to determine the content of miglitol tablets. The results are accurate and sensitive, and satisfactory results can be obtained.