A Review: Analytical Method Development and Validation
Year: 2024
Type: article
Abstract: In the process of finding new drugs, analytical development and validation are crucial. It is a continuous and inter-dependent task linked with research and development, quality assurance and quality control department. Analytical method development and validation helps to demonstrate that the technique developed it precise, accurate, linear, and robust, as well as specific to analyse a drug in pharmaceutical industry. The essential part of a study is developing the analytical methodology. Advancement in analytical instruments lead to recent development in analytical methods. The excipients, active pharmaceutical ingredient (API), degradation products, residual solvents and other related substances are developed and validated using analytical techniques. To provide accurate results, analytical method validation used. This review is focusing on the important concepts, criteria, strategies, and importance of developing analytical method and validating the developed method.
Author: Mukesh Patil*, Roshani Dhumal, Ashish Jain, Srushti Kadave, Aishwarya Patil
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6893125691
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