Low Level Determination of Genotoxic Impurity in Deferasirox Formulation

• 作者: Navin Devadiga Padmakar Sathe Pravish Kumar Tiwari
• 来源期刊: 分析科学方法和仪器期刊(英文)
• 学科: 化学
• 关键词: DEFERASIROX GENOTOXIC 4-Hydrazinobenzoic ACID HPLC
• 年，卷（期）: fxkxffhyqqkyw_2013,（4）
• 页码范围: 179-183
• 页数: 5页
• 分类号: O6

摘要

4-hydrazinobenzoic acid has been highlighted as one of the potential genotoxic impurities (PGIs). A sensitive HPLC method was developed and validated for the determination of 4-hydrazino benzoic acid in Deferasirox Tablet. HPLC method on Zorbax SB C18 column (250 × 4.6 mm i.d.), 5 μm, with UV Detector was used. The proposed method was cost effective, specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.5 μg/ml to 1.5 μg/ml with respect to the sample. The correlation coefficient was 0.999. Excellent recoveries of 102% were obtained at the level 0.5 μg/ml.