Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms

Abstract

Background: Naloxegol is a peripherally acting µ-opioid antagonist. Purpose: The aim of the present research was to develop and validate a Reverse Phase High-Performance Liquid Chromatography for quantitative determination of Naloxegol in pharmaceutical dosage forms. Methodology: HPLC system used was Shimadzu coupled to a Photodiode Array Detector and was operated in an isocratic mode. Separation was achieved using Inertsil-C18 ODS column having dimensions 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. Findings: The method was validated with regard to linearity, accuracy, precision, selectivity, and robustness in accordance with ICH guidelines. Conclusion: From this study it was concluded that the proposed method is accurate, reproducible and precise. Application: The method was applied successfully for the estimation of Naloxegol in marketed tablet dosage form. Keywords High-Performance Liquid Chromatography, Naloxegol