建立和验证大鼠血浆中枸橼酸西地那非的反相高效液相色谱法-应用于药代动力学研究。
Development and validation of RP-HPLC method for sildenafil citrate in rat plasma-application to pharmacokinetic studies.
机构信息
Department of Pharmacology, P. Wadhwani College of Pharmacy, Yavatmal, Maharashtra 445001, India.
出版信息
Saudi Pharm J. 2013 Jul;21(3):317-21. doi: 10.1016/j.jsps.2012.09.003. Epub 2012 Oct 13.
Abstract
Sildenafil citrate (SIL) is used in the treatment of erectile dysfunction and other chronic disorders. For the pharmacokinetic investigation of SIL we developed a simple and sensitive method for the estimation of SIL in rat plasma by reverse phase high-performance liquid chromatography (RP-HPLC). The drug samples were extracted by liquid-liquid extraction with 300 μl of acetonitrile and 5 ml of diethyl ether. Chromatographic separation was achieved on C18 column using methanol:water (85:15 v/v) as mobile phase at a flow rate of 1 ml/min and UV detection at 230 nm. The retention time of SIL was found to be 4.0 min having a separation time less than 5 min. The developed method was validated for accuracy, precision, linearity and recovery. Linearity studies were found to be acceptable over the range of 0.1-6 μg/ml. The method was successfully applied for the analysis of rat plasma sample for the application in pharmacokinetic study, drug interaction, bioavailability and bioequivalence.
摘要
枸橼酸西地那非（SIL）用于治疗勃起功能障碍和其他慢性疾病。为了对 SIL 的药代动力学进行研究，我们开发了一种简单灵敏的反相高效液相色谱（RP-HPLC）法，用于测定大鼠血浆中的 SIL。通过液液萃取，用 300μl 乙腈和 5ml 二乙醚提取药物样品。采用甲醇：水（85:15v/v）作为流动相，在 C18 柱上进行色谱分离，流速为 1ml/min，在 230nm 处进行紫外检测。SIL 的保留时间为 4.0min，分离时间小于 5min。该方法经过准确度、精密度、线性和回收率验证。线性研究在 0.1-6μg/ml 范围内是可以接受的。该方法成功应用于大鼠血浆样品的分析，可用于药代动力学研究、药物相互作用、生物利用度和生物等效性。
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