高效液相色谱法测定格列吡嗪缓释胶囊的释放度

HPLC Determination of the drug release of Glipizide Sustained Release Capsules

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。

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 C_(18)column(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^(-1)and the detection wavelength of 225nm.Experimenting with the apparatus II of dissolution test,using as the medium 500mL of...