QUANTITATIVE ANALYTICAL VALIDATION OF HERBAL DRUG FORMULATIONS USING UPLC AND UV-VISIBLE SPECTROSCOPY: ACCURACY, PRECISION, AND STABILITY ASSESSMENT

Abstract

This systematic review evaluates how ultra-performance liquid chromatography and UV–Visible spectrophotometry deliver quantitative analytical validation for finished herbal drug formulations, with emphasis on accuracy, precision, and stability. Following a protocol driven PRISMA process, records were de duplicated, screened in two stages by independent reviewers, and appraised with an Analytical Validation Quality Score to assess reporting completeness, validation coverage, statistical rigor, matrix handling, and stability depth, ensuring transparent selection and high reproducibility across data extraction and synthesis. In total, 115 articles met eligibility and were analyzed, contributing 204 method–analyte–matrix entries and 1,156 validation effects that encompassed recovery at defined spike levels, repeatability and intermediate precision, and multiple stability modalities. Across the corpus, pooled recovery centered at 99.3 percent, with narrow prediction intervals that indicate fit for purpose trueness in complex matrices, and repeatability clustered around practical laboratory thresholds. Platform comparisons showed a consistent but modest advantage for UPLC on tight accuracy and precision bands, while UV–Vis reached broadly acceptable performance when spectral selectivity and matrix aware calibration were emphasized; joint success across accuracy, repeatability, and at least one stability modality reached 81.4 percent overall, rising to 87.5 percent for UPLC. Design choices such as derivative or ratio derivative approaches with standard addition improved UV–Vis outcomes in liquid preparations. The evidence indicates that both platforms, paired with disciplined calibration, matrix aware sample preparation, and stability indicating design, can reliably support routine quality control and stability studies in herbal products.