Development and Validation of Hplc Methods for Quantitative Analysis of Active Pharmaceutical Ingredients (apis) in Complex Formulations
Year: 2026
Type: article
Abstract: High-Performance Liquid Chromatography (HPLC) is a powerful and widely used analytical technique for the separation, identification, purification, and quantitative determination of active pharmaceutical ingredients (APIs) in complex formulations. The technique separates components based on their interactions with the stationary phase and mobile phase and is particularly useful for pharmaceutical compounds that are non-volatile or thermally unstable. The development of an HPLC method involves several important steps, including sample preparation, selection of the appropriate chromatographic mode and column, development of the mobile phase, optimization of chromatographic conditions, selection of a suitable detector, and quantitative analysis. Method validation is performed to establish the reliability and suitability of the developed method by evaluating parameters such as accuracy, precision, linearity, specificity, robustness, and limits of detection and quantification. HPLC is extensively applied in pharmaceutical quality control, drug stability and dissolution studies, as well as clinical, forensic, environmental, food, and flavor analysis. The technique plays an important role in ensuring the quality, purity, safety, efficacy, and consistency of pharmaceutical products. Keywords: HPLC, Chromatography, Wavelength, Robustness, Manufacturing.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7221649280