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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。
Objective To establish a method for the determination of domperidone tablets dissolution by high performance liquid chromatography. Methods The chromatographic column of XDB-C18 (4.6 mm × 150 mm, 5 μm) was used with UV detector. The mobile phase consisted of 0.5% ammonium acetate and acetonitrile (65:35, V / V) The detection wavelength was 287 nm, the column temperature was 30 ℃, and the dissolution of three pharmaceutical products was determined. Results The concentration of domperidone showed a linear relationship in the range of 0.102-0.510 mg · L-1, r = 0.999 7 (n = 6), the average recovery was (100.75 ± 1.52)% and the RSD was 1.7% Product dissolution are more than 80%. Conclusion The method is sensitive, reliable and reproducible. It can be used for the determination of dissolution of domperidone tablets.