高效液相色谱法测定格列齐特缓释片的含量

Determination of Gliclazide Content in Gliclazide Sustained Release Tablets by HPLC

目的采用高效液相色谱法测定格列齐特缓释片的含量。方法采用Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水-磷酸(70∶30∶0.1),流速为0.8 mL/min,检测波长为228 nm。结果格列齐特在0.64～32μg/mL浓度范围内呈良好线性(r=0.999 9,n=7),检测限为0.5μg/mL,平均回收率为99.77%,RSD=1.07%(n=9)。结论本方法简便,准确,精密度好,适用于格列齐特缓释片的含量测定。

Objective To develop an HPLC method for the determination of Gliclazide Sustained Release Tablets.Methods Gliclazide was analyzed by the HPLC method with the C18 column.Acetonitrile-water-phosphoric acid（70：30：0.1） was used as the mobile phase with the flow rate of 0.8 mL/min and detection wavelength of 228 nm.Results Gliclazide showed good linear relation during the concentration range of 0.64-32 μg/mL（r=0.999 9,n=7）.The minimal detectable concentration of gliclazide was 0.5 μg/mL.The average recovery rate was 99.77%,RSD=1.07%（n=9）.Conclusion This method is simple and accurate with good precision,which is suitable for the determination of the gliclazide content in Gliclazide Sustained Release Tablets.