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HPLC法测定那格列奈胶囊的含量
引用本文:王兴军,许庆栋. HPLC法测定那格列奈胶囊的含量[J]. 齐鲁药事, 2011, 30(9): 511-512
作者姓名:王兴军  许庆栋
作者单位:山东华鲁制药有限公司,山东,茌平,252100
摘    要: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.

关 键 词:高效液相色谱法  那格列奈胶囊  含量测定

Determination of Nateglinide Capsule by HPLC
WANG Xing-jun,XU Qing-dong. Determination of Nateglinide Capsule by HPLC[J]. qilu pharmaceutical affairs, 2011, 30(9): 511-512
Authors:WANG Xing-jun  XU Qing-dong
Affiliation:WANG Xing-jun,XU Qing-dong(Shandong Hualu Pharmaceutical Limited Company,Chiping 252100,China)
Abstract: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.
Keywords:HPLC  Nateglinide Capsule  Determination  
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