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分光光度法与液相色谱法测定药物制剂中培哚普利和吲达帕胺的比较。

Comparison of spectrophotometric and an LC method for the determination perindopril and indapamide in pharmaceutical formulations.

作者信息

Erk N

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, University of Ankara, 06100 Ankara, Turkey.

出版信息

J Pharm Biomed Anal. 2001 Aug;26(1):43-52. doi: 10.1016/s0731-7085(01)00388-0.

Abstract

A new sensitive, simple, rapid and precise reversed-phase high performance liquid chromatographic (HPLC) and two spectrophotometric methods have been developed for resolving binary mixture of perindopril and indapamide in the pharmaceutical dosage forms. The first method is based on HPLC on a reversed-phase column using a mobile phase of phosphate buffer pH 2.4 and acetonitrile (7:3 v/v) was used. Linearity range for perindopril and indapamide was 5.0-70.0 and 8.0-35.0 microg ml(-1). In the second method, the first derivative spectrophotometry with a zero-crossing technique of measurement is used for the simultaneous quantitative determination of perindopril and indapamide in binary mixtures without previous separation step. Linear calibration graphs of first derivative values at 225.7 and 255.4 nm for perindopril and indapamide, respectively. The third method is based on ratio derivative spectrophotometry, the amplitudes in the first derivative of the ratio spectra at 226.5 and at 255.3 nm were selected to determine perindopril and indapamide in the binary mixture. All the proposed methods showed good linearity, precision and reproducibility. The proposed methods were successfully applied to the pharmaceutical dosage forms containing the above-mentioned drug combination without any interference by the excipients.

摘要

已开发出一种新的灵敏、简单、快速且精确的反相高效液相色谱(HPLC)法以及两种分光光度法,用于拆分药物剂型中培哚普利和吲达帕胺的二元混合物。第一种方法基于反相柱HPLC,使用pH 2.4的磷酸盐缓冲液和乙腈(7:3 v/v)作为流动相。培哚普利和吲达帕胺的线性范围分别为5.0 - 70.0和8.0 - 35.0 μg ml⁻¹。在第二种方法中,采用具有零交叉测量技术的一阶导数分光光度法,无需预先分离步骤即可同时定量测定二元混合物中的培哚普利和吲达帕胺。培哚普利和吲达帕胺分别在225.7和255.4 nm处的一阶导数值的线性校准曲线。第三种方法基于比率导数分光光度法,选择在226.5和255.3 nm处比率光谱一阶导数中的振幅来测定二元混合物中的培哚普利和吲达帕胺。所有提出的方法均显示出良好的线性、精密度和重现性。所提出的方法已成功应用于含有上述药物组合的药物剂型,且不受辅料的任何干扰。

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