Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: A rapid and nondestructive method

被引：70

作者：

Freitas, MP ^{[1
]}

Sabadin, A ^{[1
]}

Silva, LM ^{[1
]}

Giannotti, FM ^{[1
]}

do Couto, DA ^{[1
]}

Tonhi, E ^{[1
]}

Medeiros, RS ^{[1
]}

Coco, GL ^{[1
]}

Russo, VFT ^{[1
]}

Martins, JA ^{[1
]}

机构：

[1] Inst Int Pesquisas Farmaceut, BR-13186481 Sao Paulo, Brazil

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2005年 / 39卷 / 1-2期

关键词：

NIR diffuse reflectance; dissolution profiles; clonazepam-containing tablets;

D O I：

10.1016/j.jpba.2005.03.023

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

dA comparison between dissolution profiles obtained by using a dissolution apparatus (conventional method) and the NIR diffuse reflectance spectra of a series of clonazepam-containing batches is reported. Ten different formulations with fixed amount of clonazepam and varying proportions of excipients were analyzed at seven dissolution times and three different media. The percentages of dissolution of each sample were correlated with the NIR spectra of three tablets of each batch, through a multivariate analysis using the PLS regression algorithm. The squared correlation coefficients for the plots of percentages of dissolution from the equipment laboratory (dissolution apparatus and HPLC determination) versus the predicted values, in the leave-one-out cross-validation, varied from 0.80 to 0.92, indicating that the NIR diffuse reflectance spectroscopy method is an alternative, nondestructive tool for measurement of drug dissolution from tablets. (c) 2005 Elsevier B.V. All rights reserved.

引用

页码：17 / 21

页数：5

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