| 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。 |
| 关键词: 高效液相色谱法 米格列醇片 含量 |
| DOI： |
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| Determination of the Content of Miglitol Tablets by HPLC |
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WU Liangyong, QIU Juan
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Guangzhou Institute for Drug Control, Guangzhou 510160, China
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| 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. |
| Key words: HPLC miglitol tablets content |
