The objective of this study was to develop a new rapid and robust high-performance thin-layer chromatographic (HPTLC) method for the estimation of rivaroxaban (RRB) in tablet dosage form using a quality by design approach. Chromatography was performed using a pre-coated silica gel aluminum plate 60 F254 (10 cm × 10 cm) as the stationary phase and toluene-methanol (7:3, V/V) as the mobile phase. Detection was carried out at 250 nm. The linear regression analysis data for the calibration plots showed r2 > 0.99 with a concentration range from 100–600 ng per band. A Box–Behnken experimental design with a response surface methodology was applied to study the effects of chamber saturation time, band length, and solvent front on the RF value and area of RRB. The RF value was predicted to be 0.63 ± 0.05 for RRB to optimize the chromatographic conditions based on the preliminary trials. The optimized HPTLC method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1). The results of this study indicate that the quality by design (QbD) concept could be effectively applied to optimize a HPTLC method with a minimum number of experimental runs. The developed HPTLC method was successfully applied for routine analysis of RRB in tablet dosage form.

中文翻译：

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高质量薄层色谱方法的设计优化和验证，用于估计大批量利伐沙班及其药物剂型的质量

这项研究的目的是开发一种新的快速而强大的高性能薄层色谱法（HPTLC），用于使用质量设计方法估算片剂剂型中的利伐沙班（RRB）。色谱法使用预涂硅胶铝板60 F254（10 cm×10 cm）作为固定相，并使用甲苯-甲醇（7：3，V / V）作为流动相。检测在250nm进行。校准图的线性回归分析数据显示，r 2> 0.99，浓度范围为每条带100–600 ng。采用Box-Behnken实验设计和响应表面方法研究了室饱和时间，谱带长度和溶剂前沿对R F值和RRB面积的影响。的根据初步试验，为了优化色谱条件，RRB的R F值预计为0.63±0.05。根据国际协调会议（ICH）指南Q2（R1）对优化的HPTLC方法进行了验证。这项研究的结果表明，按设计质量（QbD）的概念可以有效地应用于以最少的实验运行次数来优化HPTLC方法。所开发的HPTLC方法已成功应用于片剂剂型中的RRB的常规分析。