Development of a Novel Chromatographic Method for Analysis of Drugs and Pharmaceutical Formulations
Abstract: Chromatographic techniques represent the cornerstone of pharmaceutical analysis, providing essential tools for quality control, drug development, and regulatory compliance. The continuous evolution of drug molecules and formulation complexity necessitates the development of novel, efficient, and robust analytical methods. This review comprehensively examines the principles, development strategies, and validation protocols associated with modern chromatographic methods for pharmaceutical analysis. The article explores various chromatographic techniques including High Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), and hyphenated methods, emphasizing their applications in drug and formulation analysis [1,2]. Key aspects of method development such as stationary phase selection, mobile phase optimization, and detection strategies are discussed in detail. The review highlights validation parameters as per International Conference on Harmonisation (ICH) guidelines, ensuring method reliability and regulatory acceptance [3]. Recent advances including green chromatography, miniaturized techniques, and the integration of artificial intelligence in method optimization are examined [4,5]. Challenges related to instrumentation costs, matrix interference, and method reproducibility are addressed alongside future perspectives on sustainable and automated analytical solutions. This comprehensive review serves as a valuable resource for pharmaceutical scientists, analytical chemists, and researchers engaged in developing innovative chromatographic methods for contemporary pharmaceutical challenges.
Keywords: Chromatographic method development, pharmaceutical analysis, HPLC, method validation, ICH guidelines, drug formulations, analytical techniques
How to Cite?: Zain Ul Bashar Khan, Dr. K. Manjuladevi, "Development of a Novel Chromatographic Method for Analysis of Drugs and Pharmaceutical Formulations", Volume 15 Issue 9, September 2026, International Journal of Science and Research (IJSR), Pages: 1796-1807, https://www.ijsr.net/getabstract.php?paperid=SR26103205700, DOI: https://dx.doi.org/10.21275/SR26103205700