Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations

被引：26

作者：

De Zan, Maria M. ^{[1
,2
]}

Camara, Maria S. ^{[1
]}

Robles, Juan C. ^{[1
]}

Kergaravat, Silvina V. ^{[1
]}

Goicoechea, Hector C. ^{[2
]}

机构：

[1] Univ Nacl Litoral, Fac Bioquim & Ciencias Biol, Catedra Quim Analit 1, Lab Control Calidad Med Mentos, Santa Fe, Argentina

[2] Univ Nacl Litoral, Fac Bioquim & Ciencias Biol, Catedra Quim Analit 1, LADAQ, Santa Fe, Argentina

来源：

TALANTA | 2009年 / 79卷 / 03期

关键词：

Miconazole; HPLC; Validation; Cream; Stability-indicating method; METRONIDAZOLE; SINGLE; DRUGS;

D O I：

10.1016/j.talanta.2009.04.060

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A simple and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of miconazole nitrate in bulk and cream preparations. The extraction step for cream samples consisted in a warming, cooling and centrifugation procedure that assures the elimination of the lipophilic matrix component, in order to avoid further precipitation in the chromatographic system. Separation was achieved on a ZORBAX Eclipse XDB - C18 (4.6 mm x 150 mm, 5 mu m particle size) column, using a mobile phase consisting of water, methanol and acetonitrile, in a flow and solvent gradient elution for 15 min. The column was maintained at 25 degrees C and 10 mu L of solutions were injected. UV detection was performed at 232 nm, although employment of a diode array detector allowed selectivity confirmation by peak purity evaluation. The method was validated reaching satisfactory results for selectivity, precision and accuracy. Degradation products in naturally aged samples could be simultaneously evaluated, without interferences in the quantitative analysis. (C) 2009 Elsevier B.V. All rights reserved.

引用

页码：762 / 767

页数：6

共 25 条

[1] Simultaneous determination of metronidazole and miconazole in pharmaceutical dosage forms by RP-HPLC [J].