Abstract

A NOVEL VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATIONOF NALOXEGOL

Y. Sirisha* and Anilkumar Y.

Abstract

A novel RP-HPLC method was developed and validated for quantitative determination of Naloxegol in pharmaceutical dosage forms. An isocratic RP-HPLC method was developed with Inertsil-C18 ODS column (250 mm × 4.6 mm, 5 μm) and the mobile phase composed of 90 volumes of methanol and 10 volumes of Acetonitrile mixture. The flow rate of the mobile phase was 1 ml min−1. Detection wavelength was 250 nm and temperature was 25 °C. The method was validated with regard to linearity, accuracy, precision, selectivity and robustness. Linearity was evaluated in the concentration range 40– 120 mg L−1. The coefficient of correlation was found to be 0.9999. The intra-day and inter-day precision values of measured concentration of naloxegol was calculated and the %RSD for intra-day and inter-day were found to be 0.05 and 0.02, respectively, demonstrating that the method was precise. Good recoveries were obtained for each concentration, confirming that the method was accurate. The limit of detection and limit of quantification for Naloxegol was found to be 2.4 ug/mL and 7.3ug/mL, respectively. The method was applied successfully for the determination of Naloxegol during kinetic studies and routine quality control analysis.

Keywords: High performance liquid chromatography, Naloxegol.