Development and Validation of an RP-HPLC Analytical Method for Oxycodone in Pharmaceutical Dosage Forms

Abstract

This research focuses on development and validation of HPLC analysis of oxycodone in pharmaceutical dosage form. A mixture of methanol:acetonitrile:water (40:40:20% v/v) at pH 4.0 was identified as the optimal choice The established technique has been validated in accordance with ICH accepted standards. Linearity and range assessments established a linear range of 50–150 µg/ml with a high correlation coefficient of 0.997. Accuracy was confirmed through recovery studies, with recoveries ranging from 97.04% to 100.83% for oxycodone. Precision was evaluated through repeatability, intra-day, and inter-day precision studies, demonstrating low relative standard deviation (RSD) values Detection sensitivity was determined by the limits of detection (LOD) and quantification (LOQ), which were found to be 0.99 µg/ml and 3.01 µg/ml, respectively. The stability of standard and sample solutions was examined at room temperature for 48 hours, with a relative standard deviation below 2.0%. The determination of oxycodone in pharmaceutical dosage forms was made possible by the present validated technique, which has exceptional specificity, linearity, precision, sensitivity, and reliability