A new robust and reliable high-performance liquid chromatography (HPLC) method with multi-criteria decision making (MCDM) approach was developed to allow simultaneous quantification of atenolol (ATN) and nifedipine (NFD) in content uniformity testing. Felodipine (FLD) was used as an internal standard (I.S.) in this study. A novel marriage between a new interactive response optimizer and a HPLC method was suggested for multiple response optimizations of target responses. An interactive response optimizer was used as a decision and prediction tool for the optimal settings of target responses, according to specified criteria, based on Derringer's desirability. Four independent variables were considered in this study: Acetonitrile%, buffer pH and concentration along with column temperature. Eight responses were optimized: retention times of ATN, NFD, and FLD, resolutions between ATN/NFD and NFD/FLD, and plate numbers for ATN, NFD, and FLD. Multiple regression analysis was applied in order to scan the influences of the most significant variables for the regression models. The experimental design was set to give minimum retention times, maximum resolution and plate numbers. The interactive response optimizer allowed prediction of optimum conditions according to these criteria with a good composite desirability value of 0.98156. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with the aid of the experimental design. The developed MCDM-HPLC method showed superior robustness and resolution in short analysis time allowing successful simultaneous content uniformity testing of ATN and NFD in marketed capsules. The current work presents an interactive response optimizer as an efficient platform to optimize, predict responses, and validate HPLC methodology with tolerable design space for assay in quality control laboratories.

开发了一种新的强大可靠的高效液相色谱（HPLC）方法，该方法具有多标准决策（MCDM）方法，可以在含量均一性测试中同时定量阿替洛尔（ATN）和硝苯地平（NFD）。非洛地平（FLD）用作本研究的内标（IS）。对于目标响应的多重响应优化，提出了新的交互式响应优化器和HPLC方法之间的新颖结合。根据Derringer的期望，交互式响应优化器被用作根据指定标准对目标响应进行最佳设置的决策和预测工具。在这项研究中考虑了四个独立变量：乙腈％，缓冲液pH和浓度以及柱温。优化了八个响应：ATN的保留时间，NFD和FLD，ATN / NFD和NFD / FLD之间的分辨率以及ATN，NFD和FLD的板号。为了扫描回归模型中最重要的变量的影响，应用了多元回归分析。实验设计设定为提供最小的保留时间，最大的分离度和板数。交互式响应优化器允许根据这些标准预测最佳条件，并具有0.98156的良好综合合意值。根据国际协调会议（ICH）指南，在实验设计的帮助下验证了所开发的方法。发达的MCDM-HPLC方法在较短的分析时间内显示出卓越的鲁棒性和分离度，从而可以成功地同时对市售胶囊中的ATN和NFD进行含量均一性测试。