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Volume 2, Issue 1
  • ISSN: 2210-299X
  • E-ISSN: 2210-3007
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Abstract

API analysis plays an important role in nourishing the quality, safety, efficacy, and potency of bulk drugs and pharmaceutical formulations. Increased drug products in the market lead to increased demand for new analytical techniques for Active Pharmaceutical Ingredient (API) analysis. During the past decades, method developments were necessitated for drug impurities, excipient profiling, and testing for biopharmaceuticals like dissolution and bioavailability. Moreover, advancements in the pharmaceutical industries necessitate upgrading newer technologies like analytical Quality by Design (QbD) and artificial intelligence. This review focused on analytical method development and its official guidelines provided by various regulatory bodies including ICH, US-FDA, AOAC, and USP. Moreover, this present art also states various validation and system parameters along with their applicability and recommended range. The critical appraisal of analytical technologies for performing various API analyses was also written in a scientific manner. Moreover, applications in recent trends in pharmaceutical industries as well as research were also documented. Hence, this review provides sufficient information for the readers for in-depth information starting from scratch to higher technologies for developing analytical methods and recent trends in the pharmaceutical industry.

© 2024 The Author(s). Published by Bentham Science Publisher.
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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2025-01-19

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/content/journals/cis/10.2174/012210299X246468231115051717
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An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications
Curr. Indian Sci. 2, E2210299X246468 (2024); https://doi.org/10.2174/012210299X246468231115051717
/content/journals/cis/10.2174/012210299X246468231115051717
/content/journals/cis/10.2174/012210299X246468231115051717
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  • Article Type:     Review Article
Keyword(s): Analytical method; API Analysis; ICH; Pharmaceutical industry; QbD; Techniques

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