Development and Validation of UV Spectrophotometric Method For Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms
Development and Validation of UV Spectrophotometric Method For Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms
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用于测定散装和药物剂型中富马酸比索洛尔的紫外分光光度法的开发和验证
DOI：
10.13171/mjc65/01710181149-shantier
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
S. Shantier
中科院分区：
文献类型：
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作者：
Shahinaz Mohammed;Mohammed E Adam;S. Shantier
本研究建立了一种简便、准确、精密的紫外分光光度法测定富马酸比索洛尔（BF）的含量。该方法基于在225 nm处测量BF水溶液的吸光度。根据ICH指导原则进行验证。标准曲线在5.0-30.0 µg/mL浓度范围内呈线性，相关系数不低于0.996。方法的检出限和定量限分别为0.22 μg/ml和0.66 μg/ml。所开发方法的日内和中间精密度反映为较低的RSD%值（分别为1.19和0.854）。回收率为100.6 ± 0.6%，n=3。该方法适用于三种不同品牌的BF含量测定。
In this study a simple, accurate and precise UV- spectrophotometric method was developed for the estimation of bisoprolol fumarate (BF) in bulk and tablet dosage form. The method was based on measurement of absorbance of BF aqueous solution at 225 nm. Validation was conducted in accordance to ICH guidelines. The calibration curve was linear in the concentration range 5.0-30.0 µg/mL with correlation coefficient not less than 0.996. The limit of detection and limit of quantification were 0.22 μg/ml and 0.66 μg/ml, respectively. Intraday and intermediate precision of the developed method were reflected by the low RSD% values (1.19 and 0.854, respectively). The recovery percentage was 100.6 ± 0.6%, n=3. The proposed method was applied for the assay of BF in three different brands.