作者
Mohamed EM Hassouna, Mahmoud A Mohamed
发表日期
2019
期刊
Glob J Oto
卷号
19
期号
3
页码范围
1-8
简介
Cefaclor (CFC), a new orally administered for the second generation of cephalosporin is the most effective for treatment of acute otitis media in children. So, the main task of this work is to develop and validate a novel RP-HPLC and RP-UPLC methods for simultaneous determination of cefaclor and methylparaben (MP) in their powder for oral suspension (POS) dosage form and in its impurity cefaclor-delta-3-isomer (CD3I). The chromatographic system is performed at ambient temperature using mobile phase composing of acetonitrile: methanol: 0.02 M ammonium dihydrogen phosphate pH 4.7±0.1 (25: 10: 65, v/v) on Agilent Eclipse XDB C18 column (250 mm X 4.6 mm, 5 μm particle size) at flow rate 1.0 mL/min, injection volume 20 μL for RP-HPLC and Waters CORTECS® C18 column (50 mm× 4.6 mm, 2.7 μm particle size) at flow rate 0.3 mL/min, injection volume 0.2 μL for RP-UPLC and UV detection at 265 nm. The method is linear for all analytes in the concentration range (70-700) μg/mL for CFC and (10-200) μg/mL for MP with correlation coefficients> 0.999. The suggested method is validated according to ICH guidelines. Hence it is suitable for laboratory control of raw materials, bulk and finished products.
引用总数
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