Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Helwan University, Cairo, 11795, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, University of Sadat City, Sadat City, 32897, Egypt.
Sci Rep. 2022 Sep 12;12(1):15319. doi: 10.1038/s41598-022-19603-9.
A green spectrofluorimetric method was introduced for the determination of selected genotoxic impurities; 2-aminopyridine and 3-aminopyridine in different pharmaceutical raw materials and dosage forms. The method relied on the native fluorescence of these impurities in acidic medium. The experimental conditions were carefully studied and optimized, and the method was validated according to International Council on Harmonisation (ICH) guidelines. The linear range for both analytes was 2.50-100 ng/mL with good determination coefficients of 0.9995 and 0.9992 and detection limits of 0.62 ng/mL and 0.74 ng/mL for 2-aminopyridine and 3-aminopyridine, respectively. The method was successfully applied for determination of 2-aminopyridine and 3-aminopyridine in four active pharmaceutical ingredients and nine dosage forms with satisfactory percentage recoveries and without interference from co-formulated excipients. Analytical performance of the proposed method was comparable to that of the reported methods; hence, the proposed method can be used as a simple and low-cost alternative in quality control laboratories.
本文建立了一种测定不同原料药和制剂中两种遗传毒性杂质 2-氨基吡啶和 3-氨基吡啶的绿色荧光分光光度法。该方法基于这些杂质在酸性介质中的本征荧光。仔细研究并优化了实验条件，并按照国际人用药品注册技术协调会（ICH）指南对方法进行了验证。两种分析物的线性范围均为 2.50-100ng/mL，具有良好的决定系数（0.9995 和 0.9992），检测限分别为 0.62ng/mL 和 0.74ng/mL。该方法成功应用于四种原料药和九种制剂中 2-氨基吡啶和 3-氨基吡啶的测定，回收率令人满意，且无赋形剂干扰。所提出的方法的分析性能与已报道的方法相当，因此，该方法可作为质量控制实验室中简单且低成本的替代方法。
