HPLC法测定吡贝地尔缓释片的释放度

Determination of drug release from piribedil release tablets by HPLC

目的：建立测定吡贝地尔缓释片释放度的方法。方法：采用HPLC法，色谱柱为ZORBAXEclipseXDB—C18（250mm×4．6mm，5μm），流动相为0．01mol·L-1庚烷磺酸钠的0．015mol·L-1磷酸二氢钾溶液（用磷酸调节pH值至3．3）-乙腈（73：27），流速为1．0mL·min-1，检测波长为286nm。结果：吡贝地尔在0．00996—0．05974mg·mL-1范围内呈良好线性关系（r=1），平均回收率为99．8％，RSD为0．28％。结论：该法灵敏度高、结果准确、重现性好，适用于吡贝地尔缓释片的释放度测定。

Objective：To establish an HPLC method for determination of drug release from piribedil sus- tained release tablets. Methods：Piribedil was separated on ZORBAX Eclipse XDB-C18 （250 mm × 4.6 mm,5 μm） column,with the mobile phase consisting of 0. 015 mol L-1 potassium dihydrogen phosphate solution （containing 0.01 mol L-1 sodium heptanesulfonate, pH adjusted to 3.3 with phosphoric acid） -acetonitrile （73 ： 27 ）. The flow rate was 1.0 mL min-1 and the detection wavelength was 286 nm. Results ： The calibration curve of piribedil was linear in the range of 0. 009 96 - 0. 059 74 mg. mL-1 （ r = 1 ）. The average recovery was 99.8% （ RSD = 0.28% ）. Conclusion ：The established HPLC method is sensitive,accurate and suitable for determination of drug release from piribedil sustained release tablets. [ Key words] piribedil; sustained release tablets ; drug release ; HPLC