Authors: Dr. Ananya Sharma, Mr. Rohan Mehta
Abstract: Analytical method development for drug impurity quantification plays a pivotal role in ensuring drug safety, efficacy, and regulatory compliance. Impurities in pharmaceuticals, arising from synthesis, degradation, or storage, can significantly impact therapeutic outcomes and patient safety. This paper presents a comprehensive overview of contemporary strategies for the development, validation, and implementation of analytical methods aimed at detecting and quantifying drug impurities. Techniques such as High Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), and capillary electrophoresis are evaluated for sensitivity, specificity, and reproducibility. Additionally, the paper highlights the importance of regulatory frameworks, method optimization parameters, and risk assessment in impurity profiling. The integration of modern analytical tools with statistical approaches enhances the robustness of impurity quantification, ensuring that pharmaceutical products adhere to the highest standards of quality.
Keywords: Drug Impurities, Analytical Method Development, HPLC, UPLC, Validation, Pharmaceutical Quality, Regulatory Compliance
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