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自动顺序注射荧光法测定和药物中酒石酸麦角新碱的溶出度研究。

Automated sequential injection fluorimetric determination and dissolution studies of Ergotamine Tartrate in pharmaceuticals.

机构信息

Laboratory of Flow Analysis, Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic.

出版信息

Talanta. 2002 Dec 6;58(6):1151-5.

PMID:18968852
Abstract

A fully automated flow system for drug-dissolution studies based on the sequential injection analysis (SIA) was described and used for monitoring dissolution profiles of Ergotamine Tartrate (ET) in pharmaceutical formulations. 50 mul of dissolution medium was taken for each measurement at a flow rate of 40 mul s(-1) and detected by fluorescence detector using lambda(ex)=236 nm (lambda(em)>/=390 nm). The calibration curve was linear over the range 0.03-0.61 mg l(-1) of ET (sufficient for the dissolution tests). Equation of the calibration curve was calculated giving the following values: F=117.7 c+0.80 (n=6); r=0.9998. Detection limit was 0.01 mg l(-1) of ET. The R.S.D. is less than 0.54 and 0.86% (n=10) when determining 0.61 and 0.03 mg l(-1) of ET in standard solution, respectively. The dissolution test of Bellaspon tablets (0.3 mg of ET in 1 tablet) was programmed for 20 min, with a continuous sampling rate of 120 h(-1) under conditions required by BP 1993.

摘要

一种基于顺序注射分析(SIA)的全自动药物溶出度研究流系统被描述并用于监测酒石酸麦角胺(ET)在药物制剂中的溶出度。在 40μl/s 的流速下,每次测量取 50μl 的溶解介质,并通过荧光检测器检测,激发波长为 236nm(发射波长大于等于 390nm)。在 0.03-0.61mg/L ET 的范围内,校准曲线呈线性(足以进行溶解试验)。校准曲线的方程式计算给出以下值:F=117.7c+0.80(n=6);r=0.9998。ET 的检测限为 0.01mg/L。当在标准溶液中分别测定 0.61 和 0.03mg/L 的 ET 时,R.S.D.分别小于 0.54%和 0.86%(n=10)。根据 BP 1993 的要求,编程对 Bellaspon 片剂(1 片含 0.3mg ET)进行 20min 的溶解试验,连续采样率为 120h-1。

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