A simple, precise, rapid and accurate high-performance thin-layer chromatographic method was developed and validated for the simultaneous estimation of emtricitabine (EMT) and tenofovir alafenamide fumarate (TAF) in combined dosage forms and forced degradation studies were carried out as per the International Council for Harmonisation (ICH) guidelines. The stationary phase used was Merck TLC silica gel 60 F₂₅₄ aluminum plates. The mobile phase used was ethyl acetate‒n-hexane‒methanol‒ammonia solution (4:4:2:0.2, V/V). Densitometric evaluation was carried out at 260 nm, EMT and TAF. The concentration ranges used for the study are 400–2000 ng/band for EMT, 50–250 ng/band for TAF. EMT and TAF gave well defined and sharp peaks at retardation factor 0.43 and 0.56, respectively. The stability study showed that samples degraded with acid, base, hydrogen peroxide and light gave well separated peaks of EMT and TAF as well as some additional peaks at different retardation factor values. The proposed method is simple, suitable, accurate and stable in accordance with the ICH guidelines.

开发并验证了一种简单、精确、快速和准确的高性能薄层色谱方法，用于同时评估联合剂型中的恩曲他滨 (EMT) 和富马酸替诺福韦艾拉酚胺 (TAF)，并根据国际协调委员会 (ICH) 指南。使用的固定相是 Merck TLC 硅胶 60 F ₂₅₄铝板。所使用的流动相是乙酸乙酯- ñ -己烷-甲醇-氨溶液（4：4：2：0.2，V / V）。在 260 nm、EMT 和 TAF 下进行光密度评估。用于研究的浓度范围为 EMT 400–2000 ng/条带，TAF 50–250 ng/条带。EMT 和 TAF 分别在延迟因子 0.43 和 0.56 处给出了明确定义的尖峰。稳定性研究表明，用酸、碱、过氧化氢和光降解的样品产生了很好分离的 EMT 和 TAF 峰，以及在不同延迟因子值下的一些附加峰。所提出的方法简单、适用、准确和稳定，符合 ICH 指南。