Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals.
Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals.
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开发和验证药物制造过程中表面上舒马曲坦琥珀酸盐残留物的液相色谱测定法。
DOI：
10.1016/s0731-7085(02)00336-9
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发表时间：
2002
影响因子：
3.4
通讯作者：
F. J. Diez
中科院分区：
文献类型：
--
作者：
M. J. Nozal;J. Bernal;L. Toribio;M. T. Martín;F. J. Diez
开发并验证了用于测定从生产设备表面收集的拭子中琥珀酸舒马曲坦残留的高效液相色谱（HPLC）方法，以控制清洁程序。使用两个用水浸湿的棉签进行擦拭测试和开发用于测定少量药物的高效液相色谱法，验证了擦拭程序。HPLC方法包括在25°C下的C18柱，磷酸二氢铵（0.05 M）-乙腈（84：16，v/v）的混合物作为移动的流动相，在228 nm下进行UV检测。乙烯基、玻璃和不锈钢板的平均回收率分别为88.5%、94.2%和95.2%，RSD分别为5.5（n=36）、2.3（n=36）、2.2%（n=36）。该方法成功地应用于从设备表面采集的真实的拭子样品的测定。
A high performance liquid chromatographic (HPLC) method for the assay of sumatriptan succinate residues in swabs collected from manufacturing equipment surfaces was developed and validated in order to control a cleaning procedure. The swabbing procedure using two cotton swabs moistened with water was validated applying a wipe-test and a HPLC method developed to determine low quantities of the drug. The HPLC method involves a C18 column at 25°C, a mixture of ammonium phosphate monobasic (0.05 M)–acetonitrile (84:16, v/v) as a mobile phase and UV detection at 228 nm. Using the proposed method, the average recoveries obtained are of 88.5% for vinyl, 94.2% for glass and 95.2% for stainless steel plates with RSD of 5.5 (n=36), 2.3 (n=36), 2.2% (n=36), respectively. The method was successfully applied to the assay of real swab samples collected from the equipment surfaces.