Optimization and Verification of A RP - HPLC Method for Analysis of Assay of Bumetanide API.

Abstract

The purity and quality of drug substances are paramount in pharmaceutical research, influencing their safety and efficacy. This study aimed to develop and validate a reliable reverse-phase ultra-performance liquid chromatography (RP-HPLC) method for the analysis of bumetanide, a potent loop diuretic associated with performance enhancement in athletics. Utilizing the Waters (Empower 2.0) equipped with a photodiode array detector, we established a method that provides enhanced resolution, speed, and sensitivity compared to traditional HPLC techniques. Materials, including HPLC-grade chemicals, were employed to formulate a mobile phase ensuring optimal performance during analysis. A 0.1% orthophosphoric acid solution was prepared for buffer use, and bumetanide was accurately quantified through a meticulously prepared standard solution. This method not only facilitates the detection of bumetanide in pharmaceutical formulations but also contributes to understanding its degradation profile. The findings affirm the effectiveness of RP-UPLC as a robust analytical tool in pharmaceutical quality control, addressing the pressing need for precise monitoring of compromised drugs.