紫外分光光度法测定黄酮酸原料药和片剂含量稳定性指示方法的建立与验证

Faizan Dosani, Nawaz Hakam, AM. Vyawahare, S. Patharkar, K. Gajbhiye
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引用次数: 2

摘要

文献调查显示,分光光度法、高效液相色谱法和高效薄层色谱法测定单一剂型和联合剂型中盐酸黄avoxate HCl含量的方法报道较少。但目前尚无单一剂型黄酮酸的紫外光谱稳定性研究报道。因此,本研究旨在建立一种简便、准确、快速、经济的紫外分光光度法测定散装和片剂中盐酸黄avoxate HCl含量的稳定性指示法。原液制备的溶剂选择为水,用相同的溶剂制备所需的浓度。检测黄酸盐HCl的λmax为211nm。黄酮类化合物在1、3、5、7、9µg/ml浓度范围内呈线性关系,回归系数(r2) 0.999。FLV在片剂中的含药率为98.81±0.39。FLV的回收率为99.11% ~ 100.49%。加样回收率接近100%,RSD < 2,表明该方法准确、精密度高。日间和日内变化分别为0.75和0.45%。检出限和定量限分别为0.719µg/ml和2.186µg/ml。考察了黄酮酸酯在水解、过氧化、热和光解(紫外和日光)降解条件下的稳定性。结果表明,黄酮酸酯在热和光解(日光和紫外光)条件下更稳定。在酸性、碱性和过氧化氢条件下,黄酮酸被大量降解。
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 Stability Indicating Method of UV-Spectrophotometry for the Estimation of Flavoxate in Bulk and Tablet Dosage form
Literature survey reveals that few spectrophotometric, high performance liquid chromatographic (HPLC) and High Performance Thin Layer Chromatographic (HPTLC) methods were reported for the estimation of Flavoxate HCl in single and in combined dosage forms. But there is no any stability indicating UV spectroscopic study is reported for Flavoxate in single dosage form. So the present study was aimed to development of simple, accurate, rapid and economical UV-spectrophotometric stability indicating assay method were established for the determination of Flavoxate HCl in bulk and tablet formulation. The solvent was selected for stock solution preparation is water and required concentrations were prepared by using the same solvent. The λmax for detection of Flavoxate HCl is 211nm. In this method Flavoxate followed linearity in the concentrations of 1, 3, 5, 7, 9µg/ml with regression coefficient (r2) 0.999. The percent drug content was found to be 98.81±0.39 for FLV in tablet formulation. Recovery study results of FLV ranges from 99.11 to 100.49%. The method was found to be accurate and precise, as indicate by recovery studies as recoveries were close to 100% and %RSD is less than 2. Inter-day and intraday variation was found to be 0.75 and 0.45%, respectively. The LOD and LOQ values were found to be 0.719µg/ml and 2.186µg/ml, respectively. The stability study of Flavoxate was investigated when the drug was subjected to hydrolytic, peroxide, heat and photolytic (UV and sunlight) degradation. The results express that the Flavoxate is under thermal and photolytic (sunlight and UV light) conditions are more stable. In acidic, basic and hydrogen peroxide conditions Flavoxate is degraded in higher amount.
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