Development and validation of a simple and efficient HPLC method for the determination of zonisamide in pharmaceuticals and human plasma

被引:3
作者
Yeniceli, Duygu [1 ]
机构
[1] Anadolu Univ, Dept Analyt Chem, Fac Pharm, TR-26470 Eskisehir, Turkey
关键词
high performance liquid chromatography; zonisamide; pharmaceutical analysis; method validation; human plasma; protein precipitation; PERFORMANCE LIQUID-CHROMATOGRAPHY; SOLID-PHASE EXTRACTION; 7 ANTIEPILEPTIC DRUGS; SERUM; CARBAMAZEPINE; LAMOTRIGINE; COLUMN; ASSAY;
D O I
10.1134/S1061934813050080
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A simple and efficient liquid chromatographic method has been developed and validated for the determination of zonisamide in pharmaceuticals and human plasma. Plasma samples are analyzed after one step protein precipitation with methanol, and chromatographic separation of zonisamide and chloramphenicol (internal standard) is carried out using a C-18 column and the optimum mobile phase of acetonitrile/methanol/distilled water (20: 10: 70, v/v/v). The method is validated in both mobile phase and human plasma, and the obtained limits of quantification values are 0.099 and 0.12 mu g/mL in mobile phase and human plasma, respectively. Fully validated method is reproducible and selective for the determination of zonisamide in pharmaceuticals and human plasma.
引用
收藏
页码:436 / 443
页数:8
相关论文
共 25 条
[1]  
[Anonymous], 2005, Validation of analytical procedures: Text and methodology Q2 (R1)
[2]  
[Anonymous], 2007, US PHARM
[3]   DETERMINATION OF ZONISAMIDE (3-SULPHAMOYLMETHYL-1,2-BENZISOXAZOLE) IN PLASMA AT THERAPEUTIC CONCENTRATIONS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
BERRY, DJ .
JOURNAL OF CHROMATOGRAPHY-BIOMEDICAL APPLICATIONS, 1990, 534 :173-181
[4]   Simultaneous HPLC-UV analysis of rufinamide, zonisamide, lamotrigine, oxcarbazepine monohydroxy derivative and felbamate in deproteinized plasma of patients with epilepsy [J].
Contin, Manuela ;
Mohamed, Susan ;
Candela, Carmina ;
Albani, Fiorenzo ;
Riva, Roberto ;
Baruzzi, Agostino .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2010, 878 (3-4) :461-465
[5]   Ruggedness and robustness testing [J].
Dejaegher, Bieke ;
Vander Heyden, Yvan .
JOURNAL OF CHROMATOGRAPHY A, 2007, 1158 (1-2) :138-157
[6]   ELECTROREDUCTION OF ZONISAMIDE AT HANGING MERCURY DROP ELECTRODE AND ITS DETERMINATION IN PHARMACEUTICAL FORMULATIONS AND SPIKED HUMAN SERUM SAMPLES [J].
Gholivand, Mohammad B. ;
Khodadadian, Mehdi ;
Majnooni, Mohammad B. ;
Bahrami, Gholamreza .
ANALYTICAL LETTERS, 2010, 43 (02) :269-279
[7]   Simultaneous determination of lamotrigine, zonisamide, and carbamazepine in human plasma by high-performance liquid chromatography [J].
Greiner-Sosanko, Elizabeth ;
Lower, Darla R. ;
Virji, Mohamed A. ;
Krasowski, Matthew D. .
BIOMEDICAL CHROMATOGRAPHY, 2007, 21 (03) :225-228
[8]  
Kromidas S., 2000, PRACTICAL PROBLEM SO
[9]  
Lakshmi PBS, 2009, ASIAN J CHEM, V21, P811
[10]   Determination of zonisamide by a coated monolithic column [J].
Li, Jing ;
Wu, Genfu ;
Zhu, Yan .
JOURNAL OF CHROMATOGRAPHY A, 2006, 1118 (01) :151-154