Aboul-Enein Hassan Y, Ali Imran
Pharmaceutical Analysis Laboratory, Biological and Medical Research Department (MBC-03), King Faisal Specialist Hospital and Research Center, P.O. Box 3354, Riyadh-11211, Saudi Arabia.
Talanta. 2005 Jan 15;65(1):276-80. doi: 10.1016/j.talanta.2004.06.012.
The simple, reliable and reproducible HPLC and extraction methods were developed for the analysis of tadalafil in pharmaceutical preparation. The column used was monolithic silica column, Chromolith Performance RP-18e (100mm x 4.6mm, i.d.). The mobile phase used was phosphate buffer (100mM, pH 3.0)-acetonitrile (80:20, v/v) at the flow rate of 5mLmin(-1) with UV detection at 230nm at ambient temperature. Extraction of tadalafil from tablet was carried out using methanol. Linearity was observed in the concentration range from 100 to 5000ngmL(-1) for tadalafil with a correlation coefficient (R(2)) 0.9999 and 100ngmL(-1) as the limit of detection. The values of linearity range, correlation coefficient (R(2)) and limit of detection were 50-5000ngmL(-1), 0.9999-50ngmL(-1), respectively for sildenafil. Parameters of validation prove the precision of the method and its applicability for the determination of tadalafil in pharmaceutical tablet formulation. The method is suitable for high throughput analysis of the drug.
开发了简单、可靠且可重现的高效液相色谱法（HPLC）和萃取方法用于分析药物制剂中的他达拉非。所用色谱柱为整体硅胶柱，Chromolith Performance RP - 18e（100mm×4.6mm，内径）。流动相为磷酸盐缓冲液（100mM，pH 3.0）-乙腈（80:20，v/v），流速为5mLmin(-1)，在室温下于230nm处进行紫外检测。采用甲醇从片剂中萃取他达拉非。他达拉非在100至5000ngmL(-1)浓度范围内呈线性，相关系数（R(2)）为0.9999，检测限为100ngmL(-1)。西地那非的线性范围、相关系数（R(2)）和检测限分别为50 - 5000ngmL(-1)、0.9999 - 50ngmL(-1)。验证参数证明了该方法的精密度及其在药物片剂制剂中测定他达拉非的适用性。该方法适用于该药物的高通量分析。
