Author: Priya Nair, Dr. Sanjay Mehta
Abstract: Analytical method development and validation are essential for ensuring the accuracy, precision, and reliability of drug quantification in pharmaceutical formulations. The objective of this study is to explore systematic strategies for developing robust analytical methods using spectroscopic and chromatographic techniques and to validate them as per regulatory guidelines. Method development involves selection of appropriate instrumentation, optimization of experimental parameters, and consideration of drug-excipient interactions. Validation ensures the method’s linearity, accuracy, precision, specificity, sensitivity, robustness, and reproducibility. Techniques such as UV-Visible spectroscopy, High-Performance Liquid Chromatography (HPLC), and Ultra-Performance Liquid Chromatography (UPLC) were evaluated for model drug formulations. Comparative analysis of calibration curves, limit of detection (LOD), limit of quantification (LOQ), and recovery studies demonstrated the suitability of the developed methods for routine quality control. A table summarizing key validation parameters for selected drugs highlights the importance of systematic evaluation. The study emphasizes the role of validated analytical methods in ensuring consistent drug quality, regulatory compliance, and patient safety.
Keywords: Analytical method development, validation, UV-Vis spectroscopy, HPLC, drug quantification, linearity, precision, accuracy, quality control
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