Rapid and sensitive determination of selective progesterone modulator ulipristal acetate in human plasma

Abstract

Ulipristal acetate is a new synthetic selective progesterone receptor modulator developed mainly as emergency contraceptive (EC) and also used for the treatment of uterine fibroids. A cost effective, sensitive, simple and rapid high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the analysis of ulipristal acetate in human plasma. Following liquid-liquid extraction, the analyte (Ulipristal acetate) and internal standard (Levonorgestrel) were chromatographed using mobile phase in an isocratic elution mode on a reverse phase C18 column. The LC-MS/MS operated in multiple reaction monitoring mode for respective [M+H] + ions, m/z 476.2/134.1 for analyte and 313.3/245.1 for internal standard. The assay exhibited linear dynamic range of 1-300 ng/mL. The lower limit of quantification was 1 ng/mL with relative standard deviation of 7.0%. The intra-batch and inter-batch results were precise with coefficient variation of 2.7 to 7.0 (%) and accuracy of 94.2-99.8 (%). The validated method was simple, fast and repeatable for bioequivalence, pharmacokinetic and therapeutic monitoring studies.

Extractive Spectrophotometric Determination of Ulipristal Acetate using Naphthol Blue Black

“…A thorough literature survey shows that LC-MS/MS [8][9] , HPLC-gradient 10 , HPLC-isocratic 11 and UV 7 methods were proposed to determine of ulipristal. Therefore, the current study reports development and validation of a flexible extractive spectrophotometric method for the determination of ulipristal in bulk drug and tablet dosage formulations.…”