High-performance liquid chromatography (HPLC) analysis of montelukast and levalbuterols: Optimizing methods, preparation, and applications in drug development

Abstract

This study aims to evaluate the methodologies and preparatory steps involved in the High-Performance Liquid Chromatography (HPLC) analysis of Montelukast and Levosalbutamol, with a focus on their relevance in pharmaceutical research and quality control. HPLC, a powerful analytical technique, is employed for the precise and reproducible determination of drug compounds in complex formulations. The study highlights the importance of meticulous sample preparation, which includes appropriate solvent selection, filtration, and dilution steps to ensure consistency and minimize matrix interference. Column selection plays a crucial role in achieving optimal separation; typically, C18 reverse-phase columns are used for their efficiency in resolving hydrophobic molecules like Montelukast and moderately polar compounds such as Levosalbutamol. Mobile phase optimization, involving a careful balance of aqueous buffers and organic modifiers (e.g., acetonitrile or methanol), is essential to attain sharp peaks, minimize tailing, and reduce analysis time. Gradient elution is often employed to enhance resolution between analytes and impurities. Calibration procedures using standard solutions of known concentrations ensure the accuracy and linearity of detection across a specified range. Validation parameters such as precision, accuracy, specificity, limit of detection (LOD), and limit of quantification (LOQ) are rigorously assessed to confirm the method's robustness. The findings of the study underscore the effectiveness of HPLC in the simultaneous or separate quantification of Montelukast and Levosalbutamol, demonstrating high resolution, minimal interference, and excellent reproducibility. This reinforces HPLC as an indispensable tool for monitoring drug stability, ensuring dosage uniformity, and maintaining therapeutic efficacy. Ultimately, the use of HPLC contributes significantly to the assurance of drug safety, compliance with pharmacopeial standards, and the overall integrity of pharmaceutical products.