Thursday , 11 July 2024

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Oxycodone and Naltrexone in Pharmaceutical Dosage Form

Ch. Sravani Phanithavya*, K.N. Maneesha, M. Sreenivasulu, Y. Prapurna Chandra
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur (V&P), Muthukur (M), SPSR Nellore District–524 346

Abstract
The aim of this study is to develop and validate a new RP-HPLC method for the Simultaneous Estimation of Oxycodone and Naltrexone in Pharmaceutical Dosage Form. The estimation of Oxycodone and Naltrexone was done by RP-HPLC. The assay of Oxycodone and Naltrexone was performed with tablets and the % assay was found to be 100.14 and 99.59 which shows that the method is useful for routine analysis. The linearity of Oxycodone and Naltrexone was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show  precision 0.7 and 0.1 for Oxycodone and Naltrexone which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show  precision 0.2 and 0.2 for Oxycodone and Naltrexone which shows that the method is repeatable when performed in different days also. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. The developed method used for routine analysis of Oxycodone and Naltrexone in different dosage forms in pharmaceutical industry.
Keywords: Oxycodone and Naltrexone, RP-HPLC, ICH guidelines, LOD, LOQ, Pharmaceutical dosage form.

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