Journal :   Asian Journal of Research in Chemistry

Volume No. :   10

Issue No. :  6

Year :  2017

Pages :   857-866

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Analytical Method Validation: Collation between International Guidelines



Address:   Dr. Advaita B. Patel
Associate Professor, Department of Pharmaceutical Chemistry, Kalol Institute of Pharmacy, Kalol, Gujarat, India
*Corresponding Author
DOI No: 10.5958/0974-4150.2017.00143.2

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.
KEYWORDS:
Analytical method validation, Guideline, Regulatory agencies, Quality.
Cite:
Advaita B. Patel. Analytical Method Validation: Collation between International Guidelines. Asian J. Research Chem. 2017; 10(6):857-866.
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