...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Talanta: The International Journal of Pure and Applied Analytical Chemistry >Validated liquid chromatographic-fluorescence method for the quantitation of darifenacin in mice plasma and its application to a pharmacokinetic study
【24h】

Validated liquid chromatographic-fluorescence method for the quantitation of darifenacin in mice plasma and its application to a pharmacokinetic study

机译：经验证的液相色谱-荧光法定量测定小鼠血浆中的darifenacin及其在药代动力学研究中的应用

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A highly selective, sensitive, and rapid high-performance liquid chromatography (HPLC) method has been developed and validated for the quantification of darifenacin in mouse plasma. Bisoprolol was used as an internal standard (IS). Darifenacin and the IS were extracted using the deproteinisation technique, followed by injection of an aliquot of the supernatant into the chromatographic system. The chromatographic separation was achieved on a reversed phase C18 column with a mobile phase of acetonitrile: 0.1% diethyl amine (pH 3.5) (60:40, v/v) pumped at a flow rate of l.0 mL min~(-1). The analytes were detected at 210 and 314 nm for excitation and emission, respectively. The assay exhibited a linear range of 100-3000 ng mL~(-1), with a lower detection limit of 35 ng mL~(-1). The method was statistically validated for linearity, accuracy, precision, selectivity and stability according to the FDA guidelines. The intra- and inter-assay coefficients of variation did not exceed 13.5% from the nominal concentration. The accuracy for darifenacin was within ±15% of the theoretical value. The assay was successfully applied in a pharmacokinetic study.
机译：已经开发了一种高度选择性，灵敏，快速的高效液相色谱（HPLC）方法，并已验证了该方法可用于定量小鼠血浆中的darifenacin。比索洛尔用作内标（IS）。使用去蛋白技术提取达那霉素和IS，然后将等分的上清液注入色谱系统。色谱分离是在反相C18色谱柱上进行的，其中以乙腈：0.1％二乙胺（pH 3.5）（60:40，v / v）的流动相泵入流速为1.0 mL min〜（-1）的色谱柱进行分离）。分别在210和314 nm处检测到分析物的激发和发射。该测定的线性范围为100-3000 ng mL〜（-1），下限为35 ng mL〜（-1）。根据FDA指南对该方法的线性，准确性，精密度，选择性和稳定性进行了统计验证。批内和批间变异系数与标称浓度之差不超过13.5％。 darifenacin的准确度在理论值的±15％以内。该测定法已成功应用于药物动力学研究。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号