HPLC标准曲线法测定格列吡嗪控释片的释放度及平均释放速率

Determination of the Drug Release and the Average Release Rates of Glipizide Extended Release Tablets by HPLC Standard Curve Method

目的用高效液相色谱标准曲线法测定格列吡嗪控释片的释放度。方法用C18柱;流动相：磷酸盐缓冲液（取磷酸二氢钠13.8g加水溶解并稀释至1000mL,用2mol/L氢氧化钠调pH至6.0）-甲醇（55∶45）;检测波长：225nm。采用标准曲线法测定释放度。结果格列吡嗪浓度在1.0~10.0μg/mL范围内与峰面积呈良好的线性关系,r=0.9998。平均加样回收率为100.19%,RSD=0.99%（n=5）。结论本方法灵敏度高、专属性强、准确可靠,较准确的反映了格列吡嗪控释片每4h的释放情况。

Objective A HPLC standard curve method has been established for the determination of the drug release of glipizide extended release tablets.Methods C18 column was used.The mobile phase was phosphate BS（dissolve 13.8g of sodium dihydrogen phosphate in water and dilute to 1000mL,adjust pH to 6.0 with 2mol L-1 sodium hydroxide）-Methonal（55∶45）.The detection wavelength was at 225 nm.The HPLC standard curve method was employed to determine the drug release.Results The linear range of 1.0~10.0μg/mL（r=0.9998） was obtained.The average recovery of add sample was 100.19%,RSD was 0.99%（n=5）.Conclusion The method was of high sensitivity and specificity,accurate,reliable.The method can reflect accurately the drug release of glipizide extended release tablets every 4 hours.