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Asian Journal of Research in Chemistry
Year : 2017, Volume : 10, Issue : 6
First page : ( 857) Last page : ( 866)
Print ISSN : 0974-4169. Online ISSN : 0974-4150.
Article DOI : 10.5958/0974-4150.2017.00143.2

Analytical Method Validation: Collation between International Guidelines

Dr. Patel Advaita B.*

Associate Professor, Department of Pharmaceutical Chemistry, Kalol Institute of Pharmacy, Kalol, Gujarat, India

*Corresponding Author E-mail: adi.pharma@yahoo.com

Online published on 26 March, 2018.

Abstract

Analytical method validation is a process use to give confirmation regarding analytical method and it is acceptable for its intended use. Analytical method validation is integral part of pharmaceutical drug development as it ensures quality, reliability, consistency and safety compliance during and post development process. Analytical method validation includes different parameters like specificity, selectivity, linearity, range, accuracy, Precision, LOD, LOQ, Robustness, Ruggedness etc. There are different guidelines for analytical method for different countries thus this review discuss salient features of different guidelines and also provides comparison of parameters with method and acceptance criteria for ICH, USFDA, AOAC, USP, JP, APVMA, IUPAC.

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Keywords

Analytical method validation, Guideline, Regulatory agencies, Quality.

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