格列齐特片剂含量与有关物质测定

目的测定格列齐特片剂的含量与有关物质。方法采用紫外分光光度法测定格列齐特片的含量,高效液相色谱法测定有关物质。结果紫外分光光度法格列齐特在5~30μg.mL-1浓度范围内线性关系良好(r=0.9999),日内、日间精密度RSD分别为0.67%和1.23%,回收率为98.75%(RSD=0.46%);HPLC法格列齐特在50~350μg.mL-1浓度范围内线性关系良好(r=0.9997),日内、日间精密度RSD分别为0.45%和1.86%,最低检测浓度为0.25ng.mL-1,杂质与主药分离良好。结论该方法控制格列齐特片的含量和有关物质方法可行。

Determination of content and related substances of Gliclazide Tablets

OBJECTIVE To establish methods for determination of content and related substances in Gliclazide Tablets.METHODS Determination of content in Gliclazide Tablets by UV and determination of related substances in Gliclazide tablets by HPLC.RESULTS The linear range of Gliclazide measured by UV was 5～30μg·mL-1(r=0.9999),day-time and with-day time precision RSD was 0.67% and 1.23%,respectively.The recovery rate was 98.75%(RSD=0.46%);The linear range of Gliclazide measured by HPLC was 50～350μg·mL-1(r=0.9997),day-time and with-day time precision RSD was 0.55% and 1.86%,respectively,with detection limit of 0.25ng·mL-1,the impurity and principal agents can be separated well.CONCLUSION This method was available for determination of content and related substances in Gliclazide Tablets.