RP-HPLC法测定格列吡嗪缓释片的释放度

RP-HPLC determination of drug release of glipizide sustained release tablets

建立了高效液相色谱法测定格列吡嗪缓释片的释放度.采用反相高效液相色谱法.固定相为ODS C18色谱柱(5μm,4.6 mm×250 mm)以0.1 mol/L磷酸二氢钠溶液(用2 mol/L氢氧化钠溶液调节pH值至(6.00±0.05)-甲醇(55∶45)为流动相,流速为1.0 mL/min.柱温室温.检测波长为225nm.采用溶出度测定法第三法装置,以0.5%十二烷基硫酸钠溶液250 mL作为释放介质,转速为50r/min,依法操作,经2、6、10 h取样测定.当格列吡嗪在释放介质中在1.019～26.49μg/mL质量浓度范围内,峰面积与质量浓度呈良好的线性关系(r=0.999 9).证明方法结果准确,不受制剂中辅料的干扰,适用于格列吡嗪缓释片的释放度测定.

This paper established an RP-HPLC method for the determination of the drug release of glipizide sustained release tablets.The RP-HPLC was on a ODS C18 column（5 μm,4.6 mm × 250 mm） at room temperature,using the mobile phase of methanol-buffer solution（0.1 mol/L sodium dihydrogen phosphate,adjusted to pH（6.00±0.05） with 2 mol/L sodium hydroxide）（55∶ 45）,at a flow rate of 1.0 mL/min and the detection wavelength of 225 nm.Glipizide was detected by the apparatus Ⅲ of dissolution,using as the medium 250 mL of 0.5% lauryl sodium sulfate solution,at 50 r/min.5 mL sample of the medium in turn at 2,6 and 10 h to determine following the above method.The calibration curve was linear in the range of 1.019~26.49 μg/mL.The method was accurate for the drug release determination of glipizide sustained release tablets.The analysis was out of interference of excipients.