Development and validation of a method for active drug identification and content determination of ranitidine in pharmaceutical products using near-infrared reflectance spectroscopy: A parametric release approach

被引：41

作者：

Rosa, Silvia S. ^{[1
,2
]}

Barata, Pedro A. ^{[2
]}

Martins, Jose M. ^{[2
]}

Menezes, Jose C. ^{[1
]}

机构：

[1] Univ Tecn Lisboa, IST, Ctr Biol & Chem Engn, P-1049001 Lisbon, Portugal

[2] Labs Atral SA, P-2600726 Castanheira, Portugal

来源：

TALANTA | 2008年 / 75卷 / 03期

关键词：

near-infrared spectroscopy; fiber optic probe; multivariate analysis; ranitidine; pharmaceutical products; validation; parametric release;

D O I：

10.1016/j.talanta.2007.12.008

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

In this paper we describe the strategy used in the development and validation of a near-infrared diffuse reflectance spectroscopy method for identification and quantification of ranitidine in pharmaceutical products (granulates, cores and coated tablets) at-line, with a fiber optic probe. This method was developed in a pharmaceutical industry for routine application, to replace reference methods and was submitted and approved to the National Medicine Regulatory Agency (infarmed). We consider that this is the first step of a broader parametric release approach to pharmaceutical products. (c) 2007 Elsevier B.V. All rights reserved.

引用

页码：725 / 733

页数：9

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