Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
An accurate, precise and robust analytical method was developed for impurity profiling of Omadacycline (Omd) bulk and tablet dosage form. Waters Alliance-E 2695 and Symmetry C18 (150x4.6mm 3.5m) column was used to separate Omadacycline and its Impurity-1(Imp-1) and Impurity-2(Imp-2). Acetonitrile, Ammonium formate (pH 2.5 adjusted with Tri Fluoro Acetic Acid (TFA) and Methanol were employed as Mobile phase (60:30:10), at flow rate of 1 ml/min, and 242nm wavelength. The peaks of Omadacycline and its impurities (1 and 2) were found at 3.64, 5.48, and 6.92 min, respectively. Omadacycline, Imp-1, and Imp-2 each had correlation coefficients of 0.9994, 0.9993, and 0.9996. Omadacycline and its impurities exhibited accuracy readings that ranged from 98.9- 100.1%, 100.1 - 100.4%, and 99.5 -100.1%, respectively. The highest degradation during the stability study was found with Peroxide (14.3%), and Thermal (0.7%) caused less degradation. The suggested approach is accurate, precise, robust, and linear.as a result, it may be utilised in quality control (QC) analysis during production to avoid the existence of impurities in pharmaceutical dosage form.