HPLC测定瑞格列奈片的含量

Content Determination of Repaglinide Tablets by HPLC

目的:建立瑞格列奈片的含量测定方法。方法:采用高效液相色谱法对瑞格列奈成分进行含量测定。色谱柱:DIKMA Diamonsil C_(18)(2)(250 mm×4.6 mm,5μm);流动相:醋酸铵缓冲液(取醋酸铵3.85 g,加水1000 m L溶解后,用冰醋酸调pH值至4.0)-甲醇(20∶80)为流动相;流速:1.0 m L/min;检测波长为243 nm;柱温为25℃;进样量为20μL。结果:瑞格列奈在10~30μg/m L范围内线性关系良好,相关系数r为0.999 6;平均回收率为100.4%,RSD为1.22%;24 h内瑞格列奈溶液稳定性良好,RSD为1.08%。结论 :本方法操作简便,结果准确、可靠,可用于瑞格列奈片的含量测定。

Objective:To develop a method for determination of content of repaglinide tablets.Methods:HPLC was used for determination of contents of various components of repaglinide tablets.DIKMA Diamonsil C18(2)column(250 mm×4.6 mm,5μm)was adopted serving ammonium acetate buffer(3.85 g ammonium acetate solution dissolved in 1 000 m L of water,of which the pH value was adjusted to 4.0 with acetic acid)-methanol(20︰80)as mobile phase at a flow rate of 1.0 m L/min.The detection wavelength was 243 nm,while the column temperature was 25℃,and the sample loading was 20μL.Results:The linear range of repaglinide was 1030μg/m L,with a r value of 0.999 6.The average recovery was 100.4%,with a RSD of 1.22%.The repaglinide solution showed good stability within 24 h,with a RSD of 1.08%.Conclusion:This method is simple,accurate and reliable,which is applicable for the quality control of repaglinide tablets.