Mehanna Mohammed M, Motawaa Abdel M, Samaha Magda W
Alexandria University, Faculty of Pharmacy, Alexandria, Egypt.
J AOAC Int. 2012 Jul-Aug;95(4):1064-8. doi: 10.5740/jaoacint.11-083.
A reliable and sensitive HPLC method was developed for the quantitation of tadalafil transdermal permeation through human skin. An RP column with UV detection at 290 nm was used for chromatographic separation at ambient temperature. The mobile phase was acetonitrile-water containing 20 mM pH 7 phosphate buffer (35/65, v/v) with a flow rate of 1.0 mL/min. The LOQ achieved was 1 ng/mL, and the calibration curve showed good linearity over the concentration range of 5-2000 ng/mL for tadalafil, with a determination coefficient (R2) of 0.998. The RSD values of intraday and interday analyses were all within 7%. Parameters of validation proved the precision of the method; this validated method was applied for the determination of tadalafil in transdermal permeation and drug deposition in human skin studies.
开发了一种可靠且灵敏的高效液相色谱法，用于定量他达拉非经人体皮肤的透皮渗透。使用在290 nm处进行紫外检测的反相柱，在室温下进行色谱分离。流动相为含20 mM pH 7磷酸盐缓冲液的乙腈-水（35/65，v/v），流速为1.0 mL/min。所达到的定量限为1 ng/mL，校准曲线在他达拉非5-2000 ng/mL的浓度范围内显示出良好的线性，决定系数（R2）为0.998。日内和日间分析的相对标准偏差值均在7%以内。验证参数证明了该方法的精密度；该经过验证的方法应用于人体皮肤研究中他达拉非的透皮渗透和药物沉积测定。
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