Development and Validation of Analytical Methods for Quantification and Dissolution of Secnidazole Tablets

被引：0

作者：

Pinto, Marcia F. ^{[1
]}

Moura, Elisana A. ^{[1
]}

Santos, Ana F. O. ^{[1
]}

Correia, Lidiane P. ^{[1
]}

Procopio, Jose V. V. ^{[1
]}

Macedo, Rui O. ^{[1
,2
]}

机构：

[1] Univ Fed Pernambuco, Dept Pharmaceut Sci, Recife, PE, Brazil

[2] Univ Fed Paraiba, Pharmaceut Dev & Assay Lab, BR-58059900 Joao Pessoa, Paraiba, Brazil

来源：

LATIN AMERICAN JOURNAL OF PHARMACY | 2014年 / 33卷 / 04期

关键词：

Dissolution; HPLC; Quantitation; Secnidazole; UV; Validation; PERFORMANCE LIQUID-CHROMATOGRAPHY; EXPERIMENTAL-DESIGN; RELEASE TABLETS; HUMAN PLASMA; OPTIMIZATION; SEPARATION; QUALITY; FORMULATION; ROBUSTNESS; STABILITY;

D O I：

暂无

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Two analytical methods were developed and validated according ICH guidelines to analyze secnidazole tablets. The HPLC method for quantification used: C8 column in 40 degrees C; mobile phase water: acetonitrile (85: 15, v/v); flow 1.0 mL/min; volume of injection 20 mu L; diode array detector at 319 nm; time of analysis 15 min. The method showed specific, linear in the range 0.025-0.150 mg/mL (r(2) = 0.999), precision (RSD < 2%), accuracy (recovery between 100.10-102.39%), and robustness. The UV method to dissolution used: 900 mL of pH 1.2 dissolution medium (simulated gastric fluid) at 37.0 +/- 0.5 degrees C; basket apparatus at stirring speed of 100 rpm. The drug release was evaluated at 276 nm, in 20 min. The method proved to be specific, linear in the range 7.5-22.5 mu g/mL (r(2) = 0.999), precise (% RSD between 2.39-3.30%), and accurate (Recovery between 102.42-103.84%). ANOVA was applied in statistical analysis.

引用

页码：613 / 623

页数：11

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