Saturday , 20 April 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Acetaminophene and oxycodone by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

V. Hari Baskar*, V. Pushpalatha, M. Gobinath, Ramesh Dhani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, Andhra Pradesh, India

The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Acetaminophine and Oxycodone in pure drug form. Chromatographic separation was done using kromosil C18  Column (250mm x 4.6mm)5µg. with mobile phase consisting Phosphate buffer: Methanol PH 2.5 (65:35 v/v)   PH was adjusted with ortho phosphoric acid and flow rate was adjusted to 1.0 ml/min and detection wavelength at 254nm. The retention times of acetaminophene Oxycodone was found to be2.589 ± 0.004 min and 3.711 ± 0.005 min. The proposed method has been validated for accuracy, precision, linearity, robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Acetaminophene and Oxycodone was found in range 20 to 60 μg/ ml and 10 to 30μg/ml and correlation coefficient was found to be 0.997 and 0.999% RSD for intermediate precision was found to be within the limits for Acetaminophene and Oxycodone. Recovery for Acetaminophene and Oxycodone was found to be 99.3% to 99.3% respectively. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition. The developed method can be successfully employed for the routine analysis of Acetaminophene and Oxycodone in API and Pharmaceutical dosage forms.
Keywords: Acetaminophene, Oxycodone, RP-HPLC, Method development, Validation.

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