The use of analytical quality by design (AQbD) approach in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool. Three factors and three levels of Box–Behnken statistical design (BBD) were used for method optimization and analysis of atorvastatin. The mobile phase (acetonitrile: water), flow rate (Rt), and UV wavelength were used as independent variables. Their effects were observed in the area of the chromatogram (AU), retention time (Rt, min), and tailing factor (%). The optimized HPLC condition was found as acetonitrile:water (50 : 50), flow rate (0.68 ml/min), and UV wave length (235 nm). It gives the retention time of 2.43 min with the linearity range of 5–30 μg/ml with a high regression value (r² = 0.999). The method was found to be precise and accurate with low % RSD (<5%). The refrigeration stability indicated that atorvastatin was stable. The force degradation study showed that the atorvastatin was fully unstable in UV light and stable in 0.1 M basic condition. It concluded that this QbD optimized method is suitable for quantification of the atorvastatin from the formulation as well as pharmacokinetic parameters.

中文翻译：

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阿托伐他汀反相高效液相色谱设计方法的分析质量：方法开发，优化，验证和稳定性指示方法

在优化高效液相色谱（RP-HPLC）方法中使用设计分析质量（AQbD）方法是一种新颖的工具。Box-Behnken统计设计（BBD）的三个因素和三个层次用于阿托伐他汀的方法优化和分析。流动相（乙腈：水），流速（Rt）和紫外线波长用作自变量。在色谱图（AU）区域，保留时间（Rt，min）和拖尾因子（％）区域观察到了它们的作用。发现优化的HPLC条件为乙腈：水（50：50），流速（0.68 ml / min）和UV波长（235 nm）。它给出了2.43分钟的保留时间与5-30线性范围 μ微克/毫升的高回归值（- [R ² = 0.999）。发现该方法是精确且准确的，且RSD低（<5％）。冷藏稳定性表明阿托伐他汀是稳定的。力降解研究表明，阿托伐他汀在紫外线下完全不稳定，在0.1 M碱性条件下稳定。结论是，此QbD优化方法适用于从制剂中定量阿托伐他汀以及药代动力学参数。