一种同时测定复方片剂中对乙酰氨基酚、抗坏血酸和盐酸伪麻黄碱的新型高效液相色谱法的开发与验证。应用于体外溶出度测试。

Development and Validation of a New HPLC Method for the Simultaneous Determination of Paracetamol, Ascorbic Acid, and Pseudoephedrine HCl in their Co-formulated Tablets. Application to in vitro Dissolution Testing.

作者信息

Ibrahim Fawzia, El-Enany Nahed, El-Shaheny Rania N, Mikhail Ibraam E

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura.

出版信息

Anal Sci. 2015;31(9):943-7. doi: 10.2116/analsci.31.943.

DOI:10.2116/analsci.31.943

PMID:26353962

Abstract

The first HPLC method was developed for the simultaneous determination of paracetamol (PC), ascorbic acid (AA), and pseudoephedrine HCl (PE) in their co-formulated tablets. Separation was achieved on a C18 column in 5 min using a mobile phase composed of methanol-0.05 M phosphate buffer (35:65, v/v) at pH 2.5 with UV detection at 220 nm. Linear calibration curves were constructed over concentration ranges of 1.0 - 50.0, 3.0 - 60.0 and 3.0 - 80.0 μg mL(-1) for PC, AA, and PE, respectively. The method was validated and applied for the simultaneous determination of these drugs in their tablets with average % recoveries of 101.17 ± 0.67, 98.34 ± 0.77, and 98.95 ± 1.11%, for PC, AA, and PE, respectively. The proposed method was also used to construct in vitro dissolution profiles of the co-formulated tablets containing the three drugs.

摘要

第一种高效液相色谱法是为同时测定复方片剂中的对乙酰氨基酚（PC）、抗坏血酸（AA）和盐酸伪麻黄碱（PE）而开发的。使用由甲醇 - 0.05 M磷酸盐缓冲液（35:65，v/v）组成的流动相，在pH 2.5条件下于C18柱上5分钟内实现分离，并在220 nm处进行紫外检测。分别在1.0 - 50.0、3.0 - 60.0和3.0 - 80.0 μg mL⁻¹的浓度范围内构建了PC、AA和PE的线性校准曲线。该方法经过验证，并应用于同时测定片剂中的这些药物，PC、AA和PE的平均回收率分别为101.17 ± 0.67%、98.34 ± 0.77%和98.95 ± 1.11%。所提出的方法还用于构建含有这三种药物的复方片剂的体外溶出曲线。