An Overview of the Design and Validation of Analytical Methods

YOGESH DADASAHEB SURVASE , MUKESH S PATIL , Dr ASHISH JAIN

Validation, Method development, Limit of quantitation, Limit of detection, Linearity, Robustness, Ruggedness

Analytical technique development, validation, and transfer are essential components of every pharmaceutical development programme. The establishment of efficient methods shows how laboratory resources can be optimized while ensuring that the objectives of each stage of drug development are met. High performance liquid chromatography is the most precise approach for both qualitative and quantitative drug analysis. The creation and validation of analytical methods are crucial for drug discovery, medication development, and pharmaceutical manufacture. It involves assessing the purity and toxicity of a pharmacological substance. A variety of chromatographic factors have been evaluated for the examination of method development in HPLC in order to optimize the techniques. A suitable mobile phase, column, column temperature, wavelength, and gradient must be developed. This review article's primary goal was to examine the creation and validation of the process used for the drug from the beginning of formulation to the final commercial batch of product. When an analytical technique is used to obtain results for the quality of samples related to medicine, it is essential that the results be trustworthy. The requirements of good manufacturing practise (GMP) laws are adhered to in the pharmaceutical industry's validation policy, which is documented for how to do validation. Validation is crucial to the efficient operation of pharmaceutical companies.

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"An Overview of the Design and Validation of Analytical Methods", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.8, Issue 3, page no.b163-b186, March-2023, Available :https://ijnrd.org/papers/IJNRD2303122.pdf

Volume 8 Issue 3, March-2023

Pages : b163-b186

Paper Reg. ID: IJNRD_188400

Published Paper Id: IJNRD2303122

Downloads: 000118837

Research Area: Pharmacy

Country: AURANAGABAD, MAHARASHTRA, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2303122

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2303122

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJNRD (IJ Publication) Janvi Wave

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