Simple, rapid, precise, accurate and specific UV-spectrophotometric method has been developed for atorvastatin calcium determination in bulk and in tablets dosage form. The method was based on using sodium citrate 0.01M as hydrotropic agent. Measurements of the UV absorbance were performed at 241 nm, and the developed method was validated as per ICH guidelines. The method obeyed Beer’s law ( R 2 = 0.999) in a concentration range of 2 – 20 μg/mL. The limits of detection (LOD) and quantification (LOQ) were 0.64 and 1.9 μg/mL, respectively. At all levels of precision, RSD% values were below 2%. Accuracy of the proposed method was ascertained by standard addition method and the percentage recovery ( n = 3) was within 100 – 100.43%. The method was applied to analysis of three atorvastatin tablet brands each claimed to contain 20 mg atorvastatin, and the percentage drug content was found to be 101.42 ± 1.56%, 99.04 ± 0.33%, and 97.71 ± 0.98%.

中文翻译：

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以柠檬酸钠为助水剂测定阿托伐他汀钙的紫外分光光度法的开发与验证

已开发出简单、快速、精确、准确和特异性的紫外分光光度法，用于测定散装和片剂剂型中的阿托伐他汀钙。该方法基于使用0.01M柠檬酸钠作为助水剂。紫外吸光度的测量在 241 nm 处进行，所开发的方法根据 ICH 指南进行了验证。该方法在 2 – 20 μg/mL 的浓度范围内遵循比尔定律 (R 2 = 0.999)。检测限 (LOD) 和定量 (LOQ) 分别为 0.64 和 1.9 μg/mL。在所有精度水平下，RSD% 值均低于 2%。建议方法的准确度由标准添加法确定，回收率 (n = 3) 在 100 – 100.43% 范围内。该方法用于分析三个阿托伐他汀片剂品牌，每个品牌声称含有 20 毫克阿托伐他汀，