Naguib Ibrahim A, Abdelaleem Eglal A, Hassan Eman S, Ali Nouruddin W
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt.
J Chromatogr Sci. 2019 Jan 1;57(1):81-86. doi: 10.1093/chromsci/bmy085.
Sensitive, selective and accurate high-performance thin layer chromatographic HPTLC method for quantitative determination of Norfloxacin (NF), Tinidazole (TZ) and 2-Methyl-5-nitroimidazole (MNZ) as potential impurity of Tinidazole is developed and validated in the presented work. Calibration curves were linear over the concentration ranges of 0.4-2.4, 0.4-1.6, 0.2-1.2 μg/band for NF, TZ and MNZ, respectively. The method depends on separation and quantitation of NF, TZ and MNZ on aluminium plates pre-coated with silica gel HPTLC 60F254 as stationary-phase using chloroform: methanol: formic acid (7.5:1: 0.3, by volume) as developing system followed by densitometric measurement of bands at 298 nm. The developed method was validated and proved to meet the requirements delineated by ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness. The validated method was successfully applied for determination of studied drugs in bulk powders and in their pharmaceutical formulation indicating the ability of proposed method to be used for routine quality control analysis of these drugs.
本文开发并验证了一种灵敏、选择性高且准确的高效薄层色谱（HPTLC）方法，用于定量测定诺氟沙星（NF）、替硝唑（TZ）以及作为替硝唑潜在杂质的2-甲基-5-硝基咪唑（MNZ）。校准曲线在NF、TZ和MNZ的浓度范围分别为0.4 - 2.4、0.4 - 1.6、0.2 - 1.2 μg/带时呈线性。该方法基于在预涂硅胶HPTLC 60F254的铝板上，以氯仿：甲醇：甲酸（体积比7.5:1:0.3）为展开系统，将NF、TZ和MNZ分离并定量，然后在298 nm处对色带进行光密度测定。所开发的方法经过验证，证明符合国际人用药品注册技术协调会（ICH）指南在线性、准确性、精密度、特异性和稳健性方面所规定的要求。该验证方法已成功应用于原料药粉末及其药物制剂中所研究药物的测定，表明所提出的方法可用于这些药物的常规质量控制分析。
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