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采用导数分光光度法测定药物制剂中的西沙必利。

Determination of cisapride in pharmaceutical preparations using derivative spectrophotometry.

作者信息

Hassan E M, Hagga M E, Al Johar H I

机构信息

Department of Analytical Chemistry, College of Pharmacy, Alexandria University, El Mesallah, Egypt.

出版信息

J Pharm Biomed Anal. 2001 Feb;24(4):659-65. doi: 10.1016/s0731-7085(00)00450-7.

DOI:10.1016/s0731-7085(00)00450-7
PMID:11272323
Abstract

Derivative spectrophotometric and high performance liquid chromatographic methods (HPLC) were described for the determination of cisapride in pharmaceutical preparations. Spectrophotometrically, cisapride was determined by measuring the 1D-values at 264, 300 nm and 2D-values at 276, 290 and 276-290 nm. Beer's Law was obeyed in the range 2-12 microg ml(-1). The HPLC method depends upon using micropack-Si-10 column at ambient temperature with a mobile phase consisting of methanol-concentrated ammonia (99.25:0.75) at a flow rate of 1 ml min(-1). Quantitation was achieved by UV detection at 272 nm using quinine as internal standard. Calibration curve was linear over the concentration range 2-10 microg ml(-1). Both derivative spectrophotometry and HPLC methods showed good linearity, precision and reproducibility. No interference was found from tablet or suspension matrices at the selected derivative wavelengths and chromatographic conditions. The proposed methods were successfully applied to the assay of commercial tablets and suspension. The procedures were rapid, simple and suitable for quality control applications.

摘要

描述了用于测定药物制剂中西沙必利的导数分光光度法和高效液相色谱法(HPLC)。采用分光光度法时,通过测量264、300nm处的一维值以及276、290和276 - 290nm处的二维值来测定西沙必利。在2 - 12μg ml⁻¹范围内符合比尔定律。HPLC法是在室温下使用微填充-Si-10柱,流动相由甲醇 - 浓氨水(99.25:0.75)组成,流速为1 ml min⁻¹。以奎宁为内标,在272nm处通过紫外检测进行定量。校准曲线在2 - 10μg ml⁻¹浓度范围内呈线性。导数分光光度法和HPLC法均显示出良好的线性、精密度和重现性。在选定的导数波长和色谱条件下,片剂或混悬液基质未发现干扰。所提出的方法成功应用于市售片剂和混悬液的含量测定。这些方法快速、简单,适用于质量控制应用。

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