Key Aspects of Analytical Method Development and Validation

Suman Shrivastava; Pooja Deshpande; S. J. Daharwal*

doi:10.52228/JRUB.2018-31-1-6

Journal of Ravishankar University

Pt. Ravishankar Shukla University, Raipur, Chhattisgarh

PART-B

(SCIENCE)

ISSN: 0970-5910

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Key Aspects of Analytical Method Development and Validation

Author(s): Suman Shrivastava, Pooja Deshpande, S. J. Daharwal*

Email(s): sumanshrivastava1991@gmail.com

Address: University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur-492010, Chhattisgarh, India. *Corresponding Author: sjdaharwal@gmail.com

Published In: Volume - 31, Issue - 1, Year - 2018

DOI: 10.52228/JRUB.2018-31-1-6

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ABSTRACT:
Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods need to be validated or revalidated. This review describes general approach towards validation process and validation parameters to be considered during validation of an analytical method. It also refers to various regulatory requirements like WHO, USFDA, EMEA, ICH, ISO/IEC. The parameters described here are according to ICH guidelines which include accuracy, precision, specificity, limit of detection, limit of quantification, linearity range and robustness.

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Cite this article:
shrivastava et al. (2018). Key Aspects of Analytical Method Development and Validation. Journal of Ravishankar University (Part-B: Science). 31 (1), pp. 32-39.DOI: https://doi.org/10.52228/JRUB.2018-31-1-6

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