Comparative analysis and validation of analytical techniques for quantification active component in pharmaceuticals: Green approach

Abstract

Methodvalidation is crucial for ensuring the reliability, accuracy, and reproducibility of analytical measurements. The primary goal is to demonstrate that an analytical method is suitable for its intended purpose. In this study, we developed and validated a method for extracting and quantifying active components from commercial β-blocker tablets. We employed Ultra-Fast Liquid Chromatography-Diode Array Detector (UFLC-DAD) and spectrophotometric techniques to validate the method, assessing key parameters such as specificity/selectivity, sensitivity, linearity, and dynamic range, limit of detection, limit of quantification, accuracy, precision, and robustness.Validation using UFLC−DAD successfully covered 50 mg and 100 mg tablets of metoprolol tartrate (MET), while the spectrophotometric method was explicitly applied to analyze the 50 mg tablets due to concentration limitations. Statistical analysis, including ANOVA and Student's t-test, indicated that both validated methods are suitable for routine analysis of MET in commercial tablets.Furthermore, we evaluated the methods' environmental impact using the analytical greenness metric approach. Findings suggest that UFLC−DAD and spectrophotometric methods contribute to an environmentally friendly overall analytical process.By systematically validating both methods and considering their environmental impact, we ensure the reliability and sustainability of observed analytical processes, thereby enhancing the quality of analytical results.