
Pharmaceutical analysis is a cornerstone of drug quality, ensuring identity, purity, safety, and efficacy across the drug lifecycle. Analytical method development and validation are essential for detecting and quantifying pharmaceutical compounds, monitoring impurities, and supporting regulatory compliance. Techniques such as UV spectroscopy and high-performance liquid chromatography (HPLC) remain widely used, with each offering unique advantages and limitations. Method validation parameters—including accuracy, precision, specificity, linearity, robustness, and sensitivity—ensure reliability and reproducibility. Recent advances like UHPLC, LC–MS/MS, diode-array detection, and green analytical approaches have further improved analytical efficiency and sustainability. Despite these innovations, challenges persist in terms of method selection, sensitivity, cost, regulatory compliance, and environmental concerns. Future directions emphasize quality by design (QbD), real-time analytical technologies, computational tools, and miniaturized portable devices, all of which aim to create faster, greener, and more robust analytical methods for pharmaceutical applications.
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