利用紫外光谱法开发和验证散装和片剂中的非诺贝特:一种抗胆固醇药物

Narender Boggula, Bhadru Banothu, Satya Sireesha Devu, Rama Rao Tadikonda, Kiran Rapolu
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引用次数: 0

摘要

分光光度法为分析存在各种干扰的多成分药物制剂中的药物提供了多功能技术。本研究开发了简单、准确、灵敏、精确和快速的紫外分光光度法,用于估算散装和片剂配方中的非诺贝特。为了确定药物非诺贝特的吸收最大值,使用双光束紫外分光光度计在 200-400nm 波长范围内以光谱测量模式进行扫描,选择 290nm 波长为取样波长,以 DMF 为溶剂。非诺贝特在 2-10 µg/ml 范围内符合比尔限。相关系数令人满意。根据 ICH 指南对所提议方法的准确度、线性、精密度、检出限(LOD)和定量限(LOQ)等验证参数进行了研究。所有参数的结果均令人满意。所提议的方法可有效地用于散装和剂型中非诺贝特的常规分析和估算。结果表明,该方法准确、精确、重现性好。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of Fenofibrate in Bulk and Tablets using UV-Spectroscopy: An Anti-Hypercholesterolemic Agent
The spectrophotometry provides versatile techniques for analyse drug in multi component pharmaceutical formulation in presence of various interferences. Simple, accurate, sensitive, precise and rapid UV-Spectrophotometric methods have been developed for the estimation of fenofibrate in bulk and tablet dosage form formulation. To determine the absorption maximum, the drug fenofibrate were scanned in wavelength range of 200-400nm in spectra measurement mode using the double beam UV-Spectrophotometer, 290 nm was selected as a sampling wavelength in DMF as solvent. Beer’s limit was obeyed in the range of 2-10 µg/ml for fenofibrate. The correlation coefficient found to be satisfactory. Validation parameters such as its accuracy, linearity, precision, limit of detection (LOD), and limit of quantitation (LOQ) was studied for proposed method according to the ICH guidelines. Results of all parameters were found to be satisfactory. The proposed method can be used effectively for routine analysis and estimation of fenofibrate in bulk and dosage form. The result demonstrated that the proposed method is accurate, precise and reproducible.  
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