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J Chromatogr Sci ; 58(5): 427-432, 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32163148

RESUMO

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.


Assuntos
Cromatografia em Camada Fina/métodos , Norpregnadienos/análise , Norpregnadienos/química , Acetatos/química , Ácido Acético/química , Estabilidade de Medicamentos , Peróxido de Hidrogênio/química , Hidrólise , Limite de Detecção , Oxirredução , Sensibilidade e Especificidade , Temperatura
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