A Validated Simple, Rapid and Accurate RP-HPLC Approach for Measuring Vardenafil Hydrochloride Trihydrate in Bulk Drugs and Medicinal Formulations

Abstract:

Background: Shortcomings in current analytical methods characterized by time-consuming procedures, limited sensitivity, and high costs associated with reagents and instruments, influence the research background. Objectives: The goal of this research was to find a simple, fast, and accurate way to discern and quantify substances in bulk drugs and finished products at the utmost minimal levels of detection and quantification. Materials and Methods: The methodology involved using a C₁₈ column then a solvent mixture comprising 0.1% orthophosphoric acid and acetonitrile in an 80:20 proportion delivered at 1 mL/min^-1 and observed at 247 nm with a UV detector. Results: Following rigorous verification in line with ICH guidelines, the technique revealed several notable features. It revealed rapidity with a retention time of 2.53 min, accurate with average recoveries ranging from 99.20% to 100.43%, precision as demonstrated by a relative standard deviation below 2%, specificity, and a highly linear correlation coefficient of 0.999 between 0.0025 to 6 µg mL^-1. Additionally, the method displayed remarkable sensitivity, detecting concentrations as low as 56.91 ng mL^-1 and a quantification limit of 172.44 ng mL^-1. Conclusion: This tested RP-HPLC method has a unique mix of speed, accuracy, and high sensitivity that makes it possible to accurately measure Vardenafil hydrochloride trihydrate, even at nanogram levels. This surpasses established techniques and offers a cost-effective solution for pharmaceutical quality control and analysis.

Keywords: RP-HPLC, Vardenafil hydrochloride Trihydrate, LOD, Nanogram.