Novel Method for Chromatographic Determination of Ulipristal Acetate in Pure Form and Formulation by Using RP-HPLC

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Jayshreemaa Biswal, Jochhana Rani Bhuyan, Nihar Ranjan Kar, Hrudesh Priyadarsan Sahoo, Binayak Mishra, Sujit Kumar Mohanty, Debashisha Panda


A method for the sensitive and exact determination of active compound Ulipristal Acetate in the bulk and marketed dosage form was developed as well as validated in this study. Ulipristal Acetate was measured in both bulk and pharmaceutical dose form. As the mobile phase, a 60:40 (v/v%) combination of acetonitrile and methanol was employed. Analyses were carried out with the help of a Symmetry C18, ODS, Reverse Phase column, with flow rates of one millilitre per minute, injection volumes of 20μl, run times of six minutes, and detection wavelengths of 275 nm. In order to verify reproducibility (within a day in triplicate) and moderate accuracy, six injections were performed. The findings were represented as percent relative standard deviation within and between days (% RSD). Analyte concentrations ranging from 20μg/ml to 50μg/ml were used to test the method's linearity. Precision investigations produced % RSD findings that were less than 0.78%, which was considered acceptable. The findings of HPLC indicates the 0.999 correlation coefficient (R2) value between the technique and the data. When used with appropriate values, the technique was also shown to be accurate and resilient. As a result, Ulipristal Acetate demonstrated the detection limit of 0.08 μg/mL and quantitation limits of 0.24 μg/mL. Using this approach, ulipristal acetate may be routinely determined in the bulk and marketed drugs, according to the study results.

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