【摘要】 目的建立高效液相色谱法测定格列吡嗪缓释胶囊的释放度。方法采用反相高效液相色谱法。固定相为ODS C18色谱柱(5μm,4.6mm×150 mm)以0.1mol/L磷酸二氢钠溶液(用2.0mol/L氢氧化钠溶液调节pH至6.00±0.05)-甲醇(50∶50)为流动相,流速为1.0mL/m in,柱温室温。检测波长为225nm。以采用溶出度测定法第二法装置,以磷酸盐缓冲液(pH7.4)500mL为释放介质,转速为每分钟100转,依法操作,经1h、4h与8h取样测定。结果当格列吡嗪在溶出介质中,在3.91~39.08μg/mL浓度范围内,吸收度与浓度成良好线性关系(r=1)。结论方法结果准确,不受制剂中辅料的干扰,适用于格列吡嗪缓释胶囊的释放度测定。更多还原

【Abstract】 OBJECTIVE To establish an HPLC method for the determination of the drug release of Glipizide Sustained Release Capsules.METHODS The RP-HPLC was on a ODS C₁₈column（5μm,4.6mm×150 mm）at room temperature,using the mobile phase of methanol-buffer solution(0.1mol·L^-1 sodium dihydrogen phosphate,adjusted to pH 7.4 with 2 mol·L^-1 sodium hydroxide)（50∶50）,at a flow rate of 1.0mL·min^-1and the detection wavelength of 225nm.Experimenting with the apparatus II of dissolution test,using as the medium 500mL of phosphate buffer solution（pH7.4）,at 100 rpm,comply with the above method,withdraw 5mL sample of the medium in turn at 1,4 and 8 hour to determine. RESULTS The calibration curve was linear in the range of 3.91～（39.08）μg·mL（r=1）.CONCLUSION The method is an accurate for the drug release determination of Glipizide Sustained Release Capsules,the analysis is out of interference of excipients.更多还原