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Performance Characteristics of UV and Visible Spectrophotometry Methods for Quantitative Determination of Norfloxacin in Tablets

机译:紫外可见分光光度法测定片剂中诺氟沙星的性能特征

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This work has proposed the development and validation of ultraviolet (UV) and visible (Vis) spectrophotometric methods for the determination of norfloxacin in the tablets. The proposed methods were applied to pharmaceutical formulation and percent amount of drug estimated (96.08% for UV method and 102.65% for Vis method) and was found in good agreement with the label claim. Using the UV method norfloxacin showed an absorption maximum at 277 nm, in 0.1 M hydrochloridric acid medium, whereas for the Vis spectrophotometric method it reacts with chloranilic acid reagent, forming a purple solution with an absorption maximum at 520 nm. The calibrations curves were linear over the working range of 2.0-7.0 μg.mL -1 for the UV method and 90.0-120.0 μg/mL for the Vis method. The linear regression equation for UV method was y = 0.1303x+0.0026 ( r 2 =0.9999) and for Vis method y = 0.0037x-0.0069 (r 2 = 0.9948), they proved to be linear. The methods were completely validated according to the International Conference Harmonization (ICH) guidelines, showing good accuracy, precision, selectivity, linearity and robustness. Therefore the both methods were found to be simple, rapid, sensitive, and easily contributing to the quality control of norfloxacin tablets while being interchangeable. ? 2014 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved. doi: http://dx.doi.org/10.3329/jsr.v6i3.18381 J. Sci. Res. 6 (3), 531-541 (2014)
机译:这项工作提出了测定片剂中诺氟沙星的紫外(UV)和可见(Vis)分光光度法的开发和验证。所提出的方法应用于药物制剂,并估计了药物的百分含量(UV方法为96.08%,Vis方法为102.65%),发现与标签要求非常一致。使用UV方法,诺氟沙星在0.1 M盐酸介质中在277 nm处显示最大吸收,而对于Vis分光光度法,它与氯苯甲酸试剂反应,形成最大吸收在520 nm的紫色溶液。对于UV方法,在2.0-7.0μg.mL-1的工作范围内,对于Vis方法,在90.0-120.0μg/ mL的工作范围内,校准曲线是线性的。 UV方法的线性回归方程为y = 0.1303x + 0.0026(r 2 = 0.9999),而Vis方法的线性回归方程为y = 0.0037x-0.0069(r 2 = 0.9948),它们被证明是线性的。这些方法已根据国际会议协调(ICH)指南进行了完全验证,显示出良好的准确性,精密度,选择性,线性和鲁棒性。因此,发现这两种方法简单,快速,灵敏,并且在可互换的情况下容易促进诺氟沙星片剂的质量控制。 ? 2014年JSR出版物。 ISSN:2070-0237(打印); 2070-0245(在线)。版权所有。 doi:http://dx.doi.org/10.3329/jsr.v6i3.18381 J. Sci。 Res。 6(3),531-541(2014)

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