Development and validation of a reversed phase liquid chromatographic method for analysis of griseofulvin and impurities

被引:13
|
作者
Kahsay, Getu [1 ]
Adegoke, Aremu Olajire [2 ]
Van Schepdael, Ann [1 ]
Adams, Erwin [1 ]
机构
[1] Katholieke Univ Leuven, Lab Farmaceut Anal, Fac Farmaceut Wetenschappen, B-3000 Louvain, Belgium
[2] Univ Ibadan, Fac Pharm, Dept Pharmaceut Chem, Orita Ul Ibadan, Nigeria
关键词
Griseofulvin; Impurities; Analysis; MS/MS; Liquid chromatography; THIN-LAYER CHROMATOGRAPHY; PHARMACEUTICAL ANALYSIS; MASS-SPECTROMETRY; TEST PARAMETERS; MINIMAL NUMBER; HUMAN PLASMA; BIOAVAILABILITY; METABOLITES; RATS;
D O I
10.1016/j.jpba.2013.02.035
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A simple and robust reversed phase liquid chromatographic method was developed and validated for the quantitative determination of griseofulvin (GF) and its impurities in drug substances and drug products (tablets). Chromatographic separation was achieved on a Discovery C-18 (250 mm x 4.6 mm, 5 mu m) column kept at 30 degrees C. The mobile phase consisted of a gradient mixture of mobile phase A (water-0.1% formic acid pH 4.5, 80:20, v/v) and B (ACN-water-0.1% formic acid pH 4.5, 65:15:20, v/v/v) pumped at a flow rate of 1.0 mL/min. UV detection was performed at 290 nm. The method was validated for its robustness, sensitivity, precision, accuracy and linearity based on ICH guidelines. The robustness study was performed by means of an experimental design and multivariate analysis. Satisfactory results were obtained from the validation studies. The use of volatile mobile phases allowed for the identification of three main impurities present above the identification threshold using mass spectrometry (MS). The developed LC method has been applied for the assay and impurity determination of GF drug substances and tablets. The method could be very useful for the quality control of GF and its impurities in bulk and formulated dosage forms. (C) 2013 Elsevier B.V. All rights reserved.
引用
收藏
页码:9 / 17
页数:9
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