Determining The Assay Of New Formulation Low Dosage Naltrexone HCl Capsules with A RP-HPLC Method

Year 2024, Volume: 7 Issue: 2, 48 - 54, 28.11.2024

E. Vildan Burgaz

https://doi.org/10.54994/emujpharmsci.1544223

Abstract

Naltrexone hydrochloride (NLX HCl) is a medication primarily used in the management of alcohol and opioid dependence. NLX HCl is an opioid antagonist that blocks the effect of opioids by binding to opioid receptors in the brain without activating them. This study aims to determine the assay amount of new formulation low dosage NLX HCl capsules by High-Performance Liquid Chromatography (HPLC). HPLC method is very precise, specific, simple, accurate and sensitive method for assay determination of new formulation NLX HCl (3.0 mg and 4.5 mg). The chromatographic separation was achieved using Eclipse XDB-12 C18 (150 mm x 4.6 mm, 5 μm particle size) column using UV detection at 280 nm. The mobile phase consisted of a variable mixture of Solution A and Solution B with gradient, run at a flow rate of 1.0 mL/min. According to our research, NLX HCl has a retention time of 10.5 minutes. The linearity range was established between 1.1-3.40 mg/mL.

Keywords

Naltrexone, Hplc, Assay, Formulation

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