Development and validation of a dissolution test for rabeprazole sodium in coated tablets

被引：23

作者：

Garcia, Cassia V. ^{[1
]}

Paim, Clesio S. ^{[1
]}

Steppe, Martin ^{[1
]}

Schapoval, Elfrides E. S. ^{[1
]}

机构：

[1] Univ Fed Rio Grande do Sul, Fac Farm, Programa Posgrad Ciencias Farmaceut, BR-90610000 Porto Alegre, RS, Brazil

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2006年 / 41卷 / 03期

关键词：

rabeprazole sodium; dissolution test; HPLC; method validation; stability; quality control;

D O I：

10.1016/j.jpba.2006.01.050

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The aim of this work is to develop and validate a dissolution test for rabeprazole sodium coated tablets using a reverse-phase liquid chromatographic method. After test sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 75 rotations per minute (rpm) stirring speed, HCI 0.1 M and borate buffer pH 9.0 as dissolution medium for acidic and basic steps, respectively, volume of 900 ml for both. The quantitation method was also adapted and validated. Less than 10% of the label amount was released in the acid step, while more than 95% was achieved over 30 min in the basic one. The dissolution profile for tablets was considered satisfactory. The dissolution test developed was adequate for its purpose and could be applied for quality control of rabeprazole tablets, since there is no official monograph. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：833 / 837

页数：5

共 22 条

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