The aim of this study is to develop a selective liquid chromatographic method for the simultaneous determination of tamsulosin HCl and dutasteride which are used for prostate treatment, in the context of an analytical column that is packed with superficially porous particles. Therefore, compositions of the mobile phase were determined for the best separation of these compounds. For this reason, experimental conditions such as varied pH values of buffer solution, temperature of the column, additives, flow rate of mobile phase and different buffer solutions were optimized. As the final condition, Kinetex C 18 analytical column (150 × 4.6; 5 µm) (Phenomenex, USA) and an acetonitrile/water 60: 40 (v/v), 0.1% o-phosphoric acid (pH adjusted to 7.0 using 5 M with NaOH) as a mobile phase are used for the best chromatographic separation. The separation was carried out at 45 °C column temperature with detection at 220 nm, and rilpivirine was chosen as an internal standard. As a result, the proposed method under optimum conditions is easy of application, rapid, precise, sensitive, accurate and fully validated. Furthermore, there is no need for time-consuming sample preparation technique, and because of this reason, it can be applied to quality control laboratories simply. Also, the optimized method can be successfully applied for the in vitro biological samples.

中文翻译：

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在表面多孔二氧化硅颗粒的背景下：同时测定生物样品中的度他雄胺和坦索罗辛

这项研究的目的是开发一种选择性液相色谱方法，用于在装有表面多孔颗粒的分析柱的背景下同时测定用于前列腺治疗的坦洛新盐酸盐和度他雄胺。因此，为了最好地分离这些化合物，确定了流动相的组成。因此，对实验条件进行了优化，例如改变缓冲溶液的pH值，色谱柱温度，添加剂，流动相的流速和不同的缓冲溶液。作为最终条件，使用Kinetex C 18分析柱（150×4.6； 5 µm）（美国，Phenomenex）和乙腈/水60:40（v / v），0.1％的邻磷酸（pH用5调节至7.0）以NaOH为流动相进行最佳色谱分离。分离在45°C柱温下进行，检测波长为220 nm，并选择rilpivirine作为内标。结果，所提出的方法在最佳条件下易于应用，快速，精确，灵敏，准确并得到充分验证。此外，不需要耗时的样品制备技术，因此，它可以简单地应用于质量控制实验室。而且，优化的方法可以成功地应用于体外生物样品。不需要耗时的样品制备技术，因此，它可以简单地应用于质量控制实验室。而且，优化的方法可以成功地应用于体外生物样品。不需要耗时的样品制备技术，因此，它可以简单地应用于质量控制实验室。而且，优化的方法可以成功地应用于体外生物样品。