A Review: Analytical Method Development and Validation

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.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-12-17
DOI
https://doi.org/10.5281/zenodo.14506357
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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0.00
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article

A Review: Analytical Method Development and Validation

Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

A Review: Analytical Method Development and Validation

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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.

Zenodo (CERN European Organization for Nuclear Research)
Industry, innovation and infrastructure
Openalex Percentile: Top 65%
Analytical Methods in Pharmaceuticals
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