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A simple Ultraviolet spectrophotometric method for the determination of etoricoxib in dosage formulations

机译:一种简单的紫外分光光度法测定剂型中的依托考昔

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The present study was undertaken to develop a validated, rapid, simple, and low-cost ultraviolet (UV) spectrophotometric method for estimating Etoricoxib (ETX) in pharmaceutical formulations. The analysis was performed on λ max 233 nm using 0.1 M HCl as blank/diluent. The proposed method was validated on International Conference on Harmonization (ICH) guidelines including parameters as linearity, accuracy, precision, reproducibility, and specificity. The proposed method was also used to access the content of the ETX in two commercial brands of Indian market. Beer's law was obeyed in concentration range of 0.1–0.5 μg/ml, and the regression equation was Y = 0.418x + 0.018. The mean accuracy values for 0.1 μg/ml and 0.2 μg/ml concentration of ETX were found to be 99.76 ± 0.52% and 99.12 ± 0.84, respectively, and relative standard deviation (RSD) of interday and intraday was less than 2%. The developed method was suitable and specific to the analysis of ETX even in the presence of common excipients. The method was applied on two different marketed brands and ETX contents were 98.5 ± 0.56 and 99.33 ± 0.44, respectively, of labeled claim. The proposed method was validated as per ICH guidelines and statistically good results were obtained. This method can be employed for routine analysis of ETX in bulk and commercial formulations.Keywords: Etoricoxib, quality control, UV spectrometry, validation
机译:进行本研究是为了开发一种有效,快速,简单且低成本的紫外(UV)分光光度法,用于估计药物制剂中的依托考昔(ETX)。使用0.1 M HCl作为空白/稀释剂,在λmax 233 nm上进行分析。该方法已在国际协调会议(ICH)指南中得到验证,包括线性,准确性,精密度,可重复性和特异性等参数。该提议的方法还用于访问印度市场上两个商业品牌中的ETX内容。在0.1-0.5μg/ ml的浓度范围内遵守比尔定律,回归方程为Y = 0.418x + 0.018。浓度为0.1μg/ ml和0.2μg/ ml的ETX的平均准确度值分别为99.76±0.52%和99.12±0.84,并且日间和日内相对标准偏差(RSD)小于2%。所开发的方法即使在存在常见赋形剂的情况下,也适用于ETX分析。该方法已应用于两个不同的市场品牌,ETX含量分别为标明权利要求的98.5±0.56和99.33±0.44。该方法已按照ICH指南进行了验证,并获得了统计上良好的结果。该方法可用于大宗和商业制剂中ETX的常规分析。关键词:依托昔布,质量控制,紫外光谱,验证

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