Validation of HPLC and UV spectrophotometric methods for the determination of bezafibrate in pharmaceutical formulations

被引:7
作者
de Melo, Janine [1 ]
Hurtado, Felipe Kellermann [2 ]
Prado, Anelise Weich [1 ]
Souza, Marines Jost e [2 ]
Rolim, Clarice Madalena Bueno [1 ]
机构
[1] Univ Fed Santa Maria, Ctr Ciencias Saude, Program Posgrad Ciencias Farmceut, BR-97105900 Santa Maria, RS, Brazil
[2] Univ Fed Santa Maria, Ctr Ciencias Saude, Dept Farm Ind, BR-97119900 Santa Maria, RS, Brazil
关键词
liquid chromatography; spectrophotometry; bezafibrate; pharmaceutical formulations; validation;
D O I
10.1080/10826070701739108
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
An isocratic high performance liquid chromatographic (HPLC) and a UV spectrophotometric method were developed and validated for the determination of bezafibrate in pharmaceutical formulations. Bezafibrate was performed on a C-18 analytical column (150 x 4.6 mm i.d., 5 mu m) with 0.01 M phosphate buffer (pH 3.5):acetonitrile:methanol (50:40:10) as mobile phase, at a flow rate of 1.0 mL min(-1). For both methods, detection was made at 230 nm. Method validation evaluated parameters such as linearity, precision, accuracy, and specificity, which remained within acceptable limits. Method comparison demonstrated that there is no significant difference between the procedures (p < 0.05).
引用
收藏
页码:269 / 280
页数:12
相关论文
共 14 条
[1]  
Ali Obaid, 2002, Pak J Pharm Sci, V15, P35
[2]   DETERMINATION OF BEZAFIBRATE IN HUMAN-PLASMA AND URINE BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
CASTOLDI, D ;
MONZANI, V ;
TOFANETTI, O .
JOURNAL OF CHROMATOGRAPHY, 1985, 344 (NOV) :259-265
[3]  
GANDINI R, 1987, PAK J PHARM SCI, V7, P149
[4]   Long-term efficacy of bezafibrate in reduction of small, dense low-density lipoprotein by hypotriglyceridemic action [J].
Hirano, T ;
Kazumi, T ;
Yoshino, G .
CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL, 2000, 61 (03) :127-136
[5]  
*ICH, 1996, VAL AN PROC TEXT MET
[6]   Separation of fibrate-type antihyperlipidemic drugs by capillary electrophoresis and their quantitation in pharmaceutical [J].
Komsta, L ;
Misztal, G ;
Majchrzak, E ;
Hauzer, A .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2006, 41 (02) :408-414
[7]  
Komsta Lukasz, 2004, Acta Pol Pharm, V61, P9
[8]   Spectrophotometric determination of bezafibrate by ternary complex formation with palladium(II) chloride and eosin [J].
Krebs, Anna ;
Starczewska, Barbara ;
Leszczynska, Edyta .
ANALYTICAL LETTERS, 2006, 39 (12) :2453-2462
[9]   COMPARATIVE PHARMACOKINETICS OF 400-MG BEZAFIBRATE AFTER A SINGLE ORAL-ADMINISTRATION OF A NEW SLOW-RELEASE PREPARATION AND THE CURRENTLY AVAILABLE COMMERCIAL FORM [J].
LEDERMANN, H ;
KAUFMANN, B .
JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 1981, 9 (06) :516-520
[10]   Determination of bezafibrate, ciprofibrate and fenofibric acid in human plasma by high-performance liquid chromatography [J].
Masnatta, LD ;
Cuniberti, LA ;
Rey, RH ;
Werba, JP .
JOURNAL OF CHROMATOGRAPHY B, 1996, 687 (02) :437-442