DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF ULIPRISTAL ACETATE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, novel, precise and accurate stability indicating RP-HPLC method was developed and validated for the estimation of Ulipristal Acetate in pharmaceutical dosage form. A Phenoxneome C18 (150 mm x 4.6 mm, 5 µm) column was used as stationary phase with mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile in the ratio of 50:50 v/v (pH was adjusted to 4.0 with triethyl amine). The flow rate was maintained at 1.0 mL/min and effluents were monitored at 223 nm. The retention time was 1.895 min. The linearity of the method was observed in the concentration range of 20-100 µg/mL with correlation coefficient of 0.999. The method developed was validated for linearity, precision, accuracy, system suitability and forced degradation studies like acidic, alkaline, oxidative and neutral stress conditions were performed as per ICH guidelines. The results obtained in the study were within the acceptable limits and hence this method can be used for the estimation of Ulipristal Acetate in pharmaceutical dosage form.