Scientific Approach To Method Development And Partial Validation Of Montelukast.

Scientific Approach to Method Development and Partial Validation of Montelukast presents a focused and systematic examination of analytical strategies used for the reliable estimation of Montelukast in pharmaceutical formulations. The book emphasizes a scientific, step-by-step approach to method development using liquid chromatography, highlighting the rationale behind the selection of chromatographic conditions such as mobile phase composition, column type, detection wavelength, and system suitability parameters. A key strength of the book lies in its clear explanation of partial method validation, covering essential performance characteristics including accuracy, precision, linearity, specificity, robustness, and sensitivity. Regulatory perspectives are carefully integrated, enabling readers to understand how validated analytical methods support quality control, stability studies, and routine assay analysis. Practical challenges commonly encountered during method development—such as peak asymmetry, resolution issues, and variability—are discussed along with effective troubleshooting strategies.