【摘要】 目的:建立抗2型糖尿病新药西格列羧的含量及有关物质的HPLC测定方法。方法:采用C18柱(150 mm×4．6 mm,5μm),流动相为甲醇-水-四氢呋喃-醋酸(35:35:30:0．5),检测波长为236 nm,流速为1．0 mL·min-1。结果:西格列羧在1.0-200μg·mL-1的浓度范围内,峰面积与浓度呈良好线性关系(r=1．0),回收率RSD小于0．2％,最低检测限为0．48 ng。结论:本方法专属、灵敏、可靠,可用于测定西格列羧的含量和有关物质。更多还原

【Abstract】 Objective: To establish a HPLC method for determination of chiglitazar, a new chemical entity for type 2 diabetes, and its related substances. Methods:The HPLC condition was consisted of aC18 column (150 mm×4.6 mm, 5μm) ; a mobile phase of methanol-H2O-tetrahydrofuran-glacial acetic acid (35:35:30:0.5) with a flow rate of 1.0 mL·min-1 and a detection wavelength at 236 nm. Results : The calibrated linear curve of chiglitazar concentrations was in the range of 1 - 200μg·mL-1 (r = 1.0) with RSD of <0.2%. The detection limit was 0.48 ng. Conclusion: This sensitive and reliable HPLC method may used to measure chiglitazar and its related substances.更多还原