A novel, rapid, and sensitive stability-indicating high-performance thin-layer chromatography method was developed and validated for the simultaneous determination of celecoxib (CEL) and diacerein (DIA) in bulk and a capsule binary mixture. The complete separation was achieved by the proposed method on nanosilica gel F₂₅₄ plates using n-hexane‒ethyl acetate‒tetrahydrofuran‒glacial acetic acid (7:3:1:0.8, V/V) as the mobile phase. The chromatographic bands were visualized using short-wave ultraviolet light, and the amount of CEL and DIA was determined by scanning densitometry at 254 nm using the peak area. The R_F values were 0.59 and 0.37 for CEL and DIA, respectively. From regression plots, it was found that good linearity was achieved in the concentration ranges of 20.00–320.00 ng/band and 5.00–80.00 ng/band with mean percentage recoveries 99.86 ± 0.70 and 99.64 ± 0.96 for CEL and DIA, respectively. The proposed method was validated according to the International Conference on Harmonisation guidelines. The statistical analysis of the results revealed high accuracy and precision, the suggested procedures could be used as a stability-indicating assay for the simultaneous determination of CEL and DIA in bulk drug and their capsule binary mixture in the presence of their degradation products.

开发了一种新颖，快速，灵敏的指示稳定性的高性能薄层色谱方法，并验证了该方法可同时测定散装的塞来昔布（CEL）和双醋瑞因（DIA）和胶囊中的二元混合物。完全分离，通过所提出的方法上的纳米二氧化硅凝胶˚F实现_254块板使用Ñ己烷-乙酸乙酯-四氢呋喃-冰醋酸（：3：1 0.8，7 V / V作为流动相）。使用短波紫外光观察色谱带，并使用峰面积通过在254 nm处的扫描光度法确定CEL和DIA的量。在[R _˚FCEL和DIA的数值分别为0.59和0.37。从回归图可以发现，在20.00–320.00 ng / band和5.00–80.00 ng / band的浓度范围内，CEL和DIA的平均回收率分别为99.86±0.70和99.64±0.96。根据国际协调大会指南对提出的方法进行了验证。结果的统计分析显示出较高的准确性和精密度，所建议的程序可作为一种稳定性指示测定法，用于在降解产物存在的同时测定散装药物及其胶囊二元混合物中的CEL和DIA。