摘要
目的建立琥珀酸曲格列汀片含量测定的高效液相色谱方法。方法采用安捷伦C18（250mm×4.6mm,5μm）色谱柱;以甲醇-0.05mol·L-1磷酸二氢钾缓冲液（取磷酸二氢钾6.8g,加水溶解并稀释至1000m L,加三乙胺2m L,用磷酸调节p H值至5.5）（30∶70）为流动相,流速：1.0m L·min-1,检测波长277nm。结果琥珀酸曲格列汀的线性范围为20-200μg·m L-1,r=1.0000,平均回收率为99.5%,RSD为0.58%（n=9）。结论该方法简便灵敏、结果准确,适用于琥珀酸曲格列汀片的质量控制。
OBJECTIVE To establish a HPLC method for the determination of Trelagliptin Succinate tablets. METHODS Agilent C18column（ 250 mm × 4. 6mm,5μm） was selected,with a mobile phase consists of methanol-0. 05mol·L- 1potassium dihydrogen phosphate buffer solution（ potassium dihydrogen phosphate 6. 8g,add water dissolved and diluted to 1000 m L,add 2m L of triethylamine,using phosphoric acid to adjust the p H to 5. 5）（ 30∶70）,The flow rate was 1. 0m L·min- 1and the detection wavelength was 277 nm. RESULTS The calibration curve was proved to be linear in the range of 20 - 2000μg·m L- 1（ r = 1. 0000）. The average recovery was 99. 5%,RSD = 0. 58%（ n = 9）. CONCLUSION The method is accurate and reliable,and can be used for quality control of Trelagliptin succinate tablets.
出处
《海峡药学》
2015年第12期48-50,共3页
Strait Pharmaceutical Journal
