A novel stability indicating RP-HPLC Method for the estimation of ulipristal - A Selective Progesterone Receptor Modulator

Abstract

The present research article described the novel HPLC technique that was developed for the estimation of ulipristal in an API and tablet formulation. Symmetry, C18, 250mm x 4.6mm .i.d., 5 µm Particle size, column with 0.4 ml/min flow rate, was used for the chromatographic separation. Phosphate buffer, pH 4.6 and methanol as a mobile phase (20:80) with a flow rate of 1 mL/min and eluent at 304 nm was monitored for the mobile phase. In compliance with ICH guidelines, the method was validated. Ulipristal was eluted in this technique with a retention time of 1.516 minutes. The limit of detection was 0.075µg/ml and the limit of quantification was found 0.25 µg/mL. The calibration curve plot was found linear over the concentration ranges 5-150 µg/mL, with the regression coefficient (R²) of 0.990. The % assay of the marketed dosage form was found at 97.40 %, which is within the acceptance level. The present method of ulipristal force degradation study was performed as per the guidelines. The results of the force degradation study show the highest 11.39% degradation in an acidic stressed condition, in comparison to alkaline, peroxide, thermal and photolytic stressed conditions. The experiential evidence of all the study results revealed the suitability of the quantification of ulipristal in API and tablet formulation routinely.