A Review on Method Development and Validation

Developing analytical methods and then validating them is a crucial step in the drug discovery process. The absence of an approved analytical technique will prevent the medicine from reaching the market, even though it has good potency. As a result, the quality and safety of the medication. In order to assess the stability of the drugs in the presence of excipients and other stress conditions encountered during their shelf life period, this review's primary goal is to provide an overview of the traditional and innovative methods available for the analysis of drugs in their raw material and formulated forms. LC-MS, LC-MS-MS, LC NMR-MS, GC-MS, and LC-MS are some of the hyphenated techniques for drug analysis and impurity profiling that are clarified by the review study.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-11-06
DOI
https://doi.org/10.5281/zenodo.14044901
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

A Review on Method Development and Validation

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

A Review on Method Development and Validation

article en

Abstract

Developing analytical methods and then validating them is a crucial step in the drug discovery process. The absence of an approved analytical technique will prevent the medicine from reaching the market, even though it has good potency. As a result, the quality and safety of the medication. In order to assess the stability of the drugs in the presence of excipients and other stress conditions encountered during their shelf life period, this review's primary goal is to provide an overview of the traditional and innovative methods available for the analysis of drugs in their raw material and formulated forms. LC-MS, LC-MS-MS, LC NMR-MS, GC-MS, and LC-MS are some of the hyphenated techniques for drug analysis and impurity profiling that are clarified by the review study.

Zenodo (CERN European Organization for Nuclear Research)
Openalex Percentile: Top 65%
Analytical Methods in Pharmaceuticals
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A Review on Method Development and Validation · Zenodo (CERN European Organization for Nuclear Research) (2024) | TGRS Research Map | TGRS