Ulipristal acetate (UPA) is used as emergency contraceptive and for uterine fibroids. No validated method has been reported to estimate UPA in presence of its degradation products. Therefore it is mandatory to develop method which can accurately measure it in presence of impurity. A simple and sensitive high-performance thin-layer chromatography (HPTLC) method was developed for the estimation of UPA. Pre-coated silica gel 60F254 TLC plates were as stationary phase and ethyl acetate:toluene:glacial acetic acid (4:7:0.3, v/v/v) was used as mobile phase. Drug was subjected to acid and alkali hydrolysis, oxidation, photo degradation and thermal degradation to study its degradation behavior. UPA eluted with Rf value 0.38 ± 0.02. The method was found to be linear in the concentration range of 400-3,600 ng/band. Limit of detection and limit of quantitation were found to be 72.7786 ng/band and 220.5412 ng/band, respectively. The % recovery of the proposed method was found to be 100.05-100.65%. The proposed method was specific to measure UPA in presence of degradants. The method was found to be accurate, precise, robust and can be useful for routine analysis of formulations containing UPA in presence of its degradation products.

中文翻译：

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存在强迫降解产物时估算乙酸树脂的HPTLC方法的优化和验证。

醋酸乙酸乙二酯（UPA）用作紧急避孕药和子宫肌瘤。尚未有经过验证的方法可以估算存在降解产物的UPA。因此，必须开发一种能够在存在杂质的情况下对其进行准确测量的方法。开发了一种简单灵敏的高性能薄层色谱法（HPTLC）来估算UPA。将预涂覆的硅胶60F254 TLC板作为固定相，并将乙酸乙酯：甲苯：冰醋酸（4：7：0.3，v / v / v）用作流动相。对药物进行了酸和碱水解，氧化，光降解和热降解，以研究其降解行为。UPA用Rf值0.38±0.02洗脱。发现该方法在400-3,600 ng / band的浓度范围内是线性的。检出限和定量限分别为72.7786 ng / band和220.5412 ng / band。发现所提出的方法的回收率为100.05-100.65％。所提出的方法专用于在存在降解物的情况下测量UPA。已发现该方法准确，精确，可靠，可用于在降解产物存在的情况下对含有UPA的配方进行常规分析。