A highly sensitive, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the quantitative determination of adapalene in the presence of its degradation products. The method employed precoated silica gel G 60 F₂₅₄ on aluminum sheets using an appropriate solvent system which gives a compact spot of adapalene at R_F value 0.58. The densitometric measurement of adapalene bands was carried out at 317 nm in fluorescence mode. The method was validated over a range of 10–100 ng/band. The linear regression data for the calibration plot showed a good relationship with high correlation coefficients. The performance of the method was validated for precision, accuracy, and robustness. The limits of detection and quantification were 1.52 and 4.61 ng/band, respectively. Adapalene was subjected to the ICH-prescribed acidic, alkaline, oxidative, photolytic, and thermal stress conditions, and it undergoes degradation with well-resolved degradation products. These degradation products were further analyzed by mass spectrometry to elucidate the structure of degradation products and proposed the prediction of the degradation pathway.

开发了一种高度灵敏，简单，准确和精确的高性能薄层色谱（HPTLC）方法，并验证了其降解产物存在下阿达帕林的定量测定。该方法在铝板上使用预涂硅胶G 60 F ₂₅₄，使用适当的溶剂系统在R _F上得到一个紧密的阿达帕林斑点。值0.58。在荧光模式下于317nm进行阿达帕林带的光密度测定。该方法在10–100 ng / band的范围内得到验证。校正图的线性回归数据显示出与高相关系数的良好关系。验证了该方法的性能的准确性，准确性和鲁棒性。检测限和定量限分别为1.52和4.61 ng / band。将阿达帕林置于ICH规定的酸性，碱性，氧化性，光解性和热应力条件下，并通过良好分解的降解产物进行降解。通过质谱法进一步分析了这些降解产物，以阐明降解产物的结构，并提出了降解途径的预测。