Stability studies of alprazolam tablets: effects of chemical interactions with some excipients in pharmaceutical solid preparations

被引：13

作者：

Castaneda, Beatriz ^{[2
]}

Ortiz-Cala, William ^{[2
]}

Gallardo-Cabrera, Cecilia ^{[2
]}

Sbarbati Nudelman, Norma ^{[1
]}

机构：

[1] Univ Buenos Aires, Dept Quim Organ, Fac Ciencias Exactas & Nat, RA-1428 Buenos Aires, DF, Argentina

[2] Univ Antioquia, Dept Farm, Fac Quim Farmaceut, Medellin, Colombia

来源：

JOURNAL OF PHYSICAL ORGANIC CHEMISTRY | 2009年 / 22卷 / 09期

关键词：

alprazolam; degradation; chemical interactions; incompatibility; excipients effects; triazolaminoquinoleine; alprazolam tablets stability; VALIDATION; PRODUCTS; DESIGN;

D O I：

10.1002/poc.1523

中图分类号：

O62 [有机化学];

学科分类号：

070303 ; 081704 ;

摘要：

An HPLC method was developed to determine the stability of alprazolam (AL) as a pure drug and in monodrug pharmaceutical tablets. The main degradation product of AL tablets was isolated and fully characterized as triazolaminoquinoleine (TAQ). For a quantitative evaluation of the excipient effects in the pharmaceutical formulations, a 2(k) fractionated factorial design was applied in the preparation of the different samples. The kinetic of degradation of AL in each formulation was followed by UV spectrophotometry. It was found that excipients like CMC and magnesium stearate favour degradation, while the rate of the reaction is decreased when lactose and starch were used as excipients. A mechanism for the interactions of AL with some excipients is postulated that explains the observed results. Copyright (C) 2009 John Wiley & Sons, Ltd.

引用

页码：807 / 814

页数：8

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