HPLC法测定那格列奈胶囊的含量

目的建立那格列奈胶囊的高效液相色谱含量测定方法.方法采用PhenomenexODS-3 C18(150mm×4.6mm,5μm)色谱柱;以乙腈-甲醇-0.05 mo·lL-1磷酸氢二钾溶液(用磷酸调节pH至6.0)(35∶10∶55)为流动相;流速1.0mL·min-1,检测波长为210 nm,柱温35℃.结果那格列奈在浓度8～80μg·mL-1范围内具有良好的线性关系(r=0.999 3).平均回收率为99.9%,RSD为0.36%(n=9).结论此方法简便、准确、灵敏度高,适用于那格列奈胶囊的质量控制.

Determination of Nateglinide Capsule by HPLC

Objective To establish an HPLC method for the determination of Nateglinide Capsule.Methods Phenomenex ODS-3 C18（150 mm× 4.6 mm,5 μm）Column was adopted,the mobile phase consisted of acetonitrile-methanol-0.05 mol·L-1 dibasic potassium phosphate（adjusted pH6.0 with phosphoric acid）（35∶ 10∶ 55）,the flow rate was 1.0 mL·min-1,the detection wavelength was 210 nm,the column temperature was 35 ℃.Results A good linear relationship was observed in the concentration range of 8～80 μg·mL-1（r=0.999 3）,the average recovery was 99.9%,RSD=0.36%（n=9）.Conclusion The method was simple,accurate and sensitive,and was suitable for the quality control of Nateglinide Capsule.