Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review)-Reference-Cited by-同舟云学术

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Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review)

Published:2020-08-29 Issue:3 Volume:9 Page:129-136
ISSN:2658-5049
Container-title:Drug development & registration
language:
Short-container-title:Razrabotka i registraciâ lekarstvennyh sredstv

Author:

Epshtein N. A.¹^ORCID

Affiliation:

1. Department of registration and development of medicines LLC «IRVIN 2»

Publisher

Center of Pharmaceutical Analytics Ltd

Subject

Drug Discovery,Pharmaceutical Science

Reference30 articles.

1. ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). ICH, 2005. 13 p.

2. United States Pharmacopoeia. <1225> Validation of compendial procedures. USP41-NF36. 2018.

3. Guidance on the validation of analytical methods for testing drugs. EAEU. 2018. 25 с. (In Russ.).

4. Bylund D., Danielsson R., Markides K. E. Peak purity assessment in liquid chromatography-mass spectrometry. J. Chromatography A. 2001;915: 43-52. Doi: https://doi.org/10.1016/S0021-9673(01)00543-X.

5. Dyrstad K., Hvattum Er., Jara S., Lie A. Peak-purity by LC-MS and LC-DAD (presentation). 2015.

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