HPLC method for the determination of nifedipine in rat plasma: development, validation, and application to pharmacokinetic drug-herb interaction study

Devy N. A. Hasanuddin, Afrillia Nuryanti Garmana, Lucy Sasongko
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Abstract

A simple and rapid high-performance liquid chromatography (HPLC) was developed to determine the plasma level of nifedipine in rats after its single administration and combination with herbs. Nifedipine was extracted with acetonitrile to precipitate protein from plasma samples. The separation was implemented on a C18 column with a mobile phase of acetonitrile: water (63:37, v/v). The calibration curve displayed good linearity in the 30–1000 ng/mL range. The lower limit of quantification (LLOQ) was 30 ng/mL. The intraday and interday assay accuracy and precision met the criteria of validation and study sample analysis. The recovery was found to be 101.89%. Stability studies showed that nifedipine was stable after 12 h at room temperature and 21 days at -20 °C. No significant difference was examined between the pharmacokinetic parameters of nifedipine with or without Gynura procumbens leaf extract. The proposed method was helpful for the pharmacokinetic interaction study of nifedipine combined with herbal in rats.
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测定大鼠血浆中硝苯地平含量的高效液相色谱法的建立、验证及在药物-草药相互作用研究中的应用
本研究开发了一种简便、快速的高效液相色谱法(HPLC),用于测定大鼠单服或与中草药合用后血浆中硝苯地平的含量。用乙腈提取硝苯地平,沉淀血浆样品中的蛋白质。采用 C18 色谱柱,以乙腈:水(体积比为 63:37)为流动相进行分离。校准曲线在 30-1000 纳克/毫升范围内显示出良好的线性。定量下限(LLOQ)为 30 纳克/毫升。日内和日间测定的准确度和精密度符合验证和研究样品分析的标准。回收率为 101.89%。稳定性研究表明,硝苯地平在室温下 12 小时和 -20 °C 下 21 天后稳定。硝苯地平的药代动力学参数在添加或不添加绞股蓝叶提取物时无明显差异。该方法有助于硝苯地平与中药大鼠药代动力学相互作用的研究。
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