High-performance liquid chromatography-based analytical techniques for simultaneous determination of Naltrexone hydrochloride (NTX) and Bupropion hydrochloride (BUP): a comprehensive review

Abstract

The confluence of Bupropion Hydrochloride and Naltrexone Hydrochloride within a composite pharmaceutical formulation has garnered the prestigious endorsement of the U.S. Food and Drug Administration (FDA) for its targeted application in addressing the pervasive issue of obesity. Naltrexone hydrochloride, a semi-synthetic opioid compound, exerts its therapeutic influence through competitive antagonism of the mu receptors, while Bupropion hydrochloride, a tricyclic antidepressant, operates by impeding the reuptake of dopamine, thus amplifying its activity in distinctive cerebral domains. Notably, Naltrexone's impact is modulated through the intricate manipulation of pro-opiomelanocortin neurons within the hypothalamus, underscoring the amalgamated efficacy of this unique tandem in the protracted management of obesity. This scholarly exposition focalizes on the meticulous delineation of high-performance liquid chromatography (HPLC)-based analytical methodologies, meticulously tailored for the concurrent quantification of naltrexone hydrochloride (NTX) and bupropion hydrochloride (BUP). This comprehensive review scrutinizes an array of analytical strategies, traversing from archetypal HPLC (high performance liquid chromatography) methodologies to the burgeoning realm of environmentally conscious chromatographic approaches. Each method undergoes scrupulous examination, elucidating the nuanced applications, from the constitution of the mobile phase and judicious column selection to the refinement of optimal flow rates. Moreover, the review orchestrates a comprehensive evaluation of the validation parameters intrinsic to these analytical approaches, fortifying the reliability and precision of their findings. This erudite exploration not only encapsulates the diversity of chromatographic techniques but also expounds on the methodological robustness that underpins the determination of these pharmacologically significant compounds. In doing so, it elevates the pursuit of scientific excellence in pharmaceutical analysis, contributing significantly to the ongoing discourse in this critical field.

Article Highlights

Explores wide range of HPLC based analytical procedures for simultaneous estimation of Naltrexone HCl and Bupropion HCl.

Comprehensive evaluation of validation parameters to increase reliability and precision of methods.

Simultaneous estimation of different API’s is advantageous in terms of saving cost, time, energy and resources

Validates HPLC as an accurate, robust and technique of choice as an analytical tool.