Safety and human health: The landscape of an effective UPLC-MS/MS method for the identification and quantification of N-Nitroso Hydrochlorothiazide impurity in Hydrochlorothiazide

Author:

Bhimireddy Anuradha,Shanmukha Kumar J.V.,Prasada Reddy Chittireddy H.N.,Rafi Shaik Mohammed,Assal Mohamed E.,Khan Mujeeb

Funder

King Saud University

Publisher

Elsevier BV

Reference40 articles.

1. Acceptable intakes established for N-nitrosamines , European Medicines Agency, 28 September 2023 EMA/315970/2023 rev.1, https://www.ema.europa.eu/en/documents/other/appendix-1-acceptable-intakes-established-n-nitrosamines_.pdf.

2. Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry, https://www.fda.gov/files/drugs/published/Analytical-Procedures-and-Methods-Validation-for-Drugs-and-Biologics.pdf,.

3. Development and validation of a UV spectrophotometric method for the simultaneous estimation of eprosartan mesylate and hydrochlorothiazide in bulk and formulations;Anandakumar;Indian J. Pharm. Sci.,2011

4. Mutagenicity of amine drugs and their products of nitrosation;Andrews;Mutation Research/genetic Toxicology,1984

5. Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities;Ashworth,2023

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