Validated UPLC Method for Organic Impurities of Phenazopyridine Hydrochloride Drug. A Green Analytical Technique

Abstract

Introduction: Green Chemistry talks about any environmental technique or practice which may reduce waste, materials, hazards, risk, energy, environmental impact, and operational cost, also increase productivity. Ultra performance liquid chromatography (UPLC) is novel technique of High-performance Liquid chromatography (HPLC), which is a Green Technique in the true sense. To enhance those practices, a simple, sensitive, accurate, selective, and precise Ultra Performance Liquid Chromatography (UPLC) method was developed for the identification and quantification of the Phenazopyridine Hydrochloride Drug. The separation was performed on a BEH C18-column (1.7 µm, 2.1 mm X 100 mm) using a mobile phase20 mM ammonium acetate buffer as mobile phase-A and 100% Acetonitrile as a mobile phase-B ingredient elution. The detection was performed at fixed wavelength (λ=240nm) injection volume (1.5μl), with a flow rate of 0.40ml/min and Run Time 9.0 Minutes. The retention time of Phenazopyridine Hydrochloride was found at about 4.64 minutes. After developing the method, it was assured for future use by validation of the analytical parameters like System Suitability, Specificity, linearity, accuracy, precision, solution stability, The Limit of Detection (LOD) and Limit of Quantification (LOQ) and robustness. The results of all the parameters of the method were found within the acceptance criteria as per the International Council for Harmonization (ICH) guidelines and general practices of pharmaceutical industries.

DOI: https://doi.org/10.52783/jchr.v14.i2.3589