高效液相色谱法测定多潘立酮片溶出度

Determination of dissolution of domperidone tablets by HPLC

目的建立多潘立酮片溶出度的高效液相色谱测定方法。方法采用XDB-C18色谱柱(4.6 mm×150 mm,5μm),紫外光度检测器,流动相为0.5%醋酸铵∶乙腈(65∶35,V/V),流速为1.0 mL.min-1,检测波长为287 nm,柱温为30℃,并对3个药厂的产品进行溶出度测定。结果多潘立酮片浓度在0.102～0.510 mg.L-1范围内呈线性关系,r=0.999 7(n=6),平均回收率为(100.75±1.52)%,RSD为1.7%,3个药厂的产品溶出度均在80%以上。结论该方法灵敏、结果可靠、重现性好,可用于多潘立酮片的溶出度测定。

AIM To establish a HPLC method for determining the dissolution of domper/done tablets. METHODS The separation was performed on a XDB-C18 column （4.6 mm ×150mm, 5 μm） with a mobile phase of 0.5% ammonium acetate-acetonitrile （65 ： 35, V/V） at a flow rate of 1.0 mL .min-1. The detection wavelength was 287 nm and the column temperature was 30℃. Three pharmaceutical products were evaluated. RESULTS The calibration curve of domperidone was linear in the range of 0.102 - 0.510 mg·L-1 （r = 0.999 7）, the average recovery was （100.75± 1.52）% with a RSD of 1.7%. All dissolutions were more than 80%. CONCLUSION The method is sensitive, accurate, reliable and suitable for determining the dissolution of domperidone tablets.