Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N‐nitrosodimethyl amine and N‐nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and extended‐release formulations-Reference-Cited by-同舟云学术

Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N‐nitrosodimethyl amine and N‐nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and extended‐release formulations

Published:2022-07-15 Issue:16 Volume:45 Page:3067-3081
ISSN:1615-9306
Container-title:Journal of Separation Science
language:en
Short-container-title:J of Separation Science

Author:

Mallavarapu Ravindra¹,Katari Naresh Kumar¹²^ORCID,Siddhani Vijaya Krishna³,Marisetti Vishnu Murthy⁴,Rekulapally Vijay Kumar⁵,Vyas Govind⁶,Jonnalagadda Sreekanth Babu²

Affiliation:

1. Department of Chemistry, GITAM School of Science GITAM Deemed to be University Hyderabad Telangana 502329 India

2. School of Chemistry and Physics, College of Agriculture, Engineering and Science Westville Campus, University of KwaZulu‐Natal P Bag X 54001 Durban 4000 South Africa

3. Regulatory Affairs ScieGen Pharmaceuticals Inc 330 Oser Avenue Hauppauge New York 11788 USA

4. Analytical Research and Development ScieGen Pharmaceuticals Inc 89 Arkay Drive Hauppauge New York 11788 USA

5. Analytical Research and Development Hikma Pharmaceuticals USA Inc Columbus Ohio 43228 USA

6. Research and Development and Regulatory Compliance Invahealth Inc. 1212 South River Road Cranbury New Jersey 08512 USA

Publisher

Wiley

Subject

Filtration and Separation,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jssc.202200226

Reference20 articles.

1. ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk ICH M7 2018.

2. https://www.fda.gov/drugs/drug‐safety‐and‐availability/information‐about‐nitrosamine‐impurities‐medications“Information about Nitrosamine Impurities in Medications”

3. https://www.ema.europa.eu/en/human‐regulatory/post‐authorisation/referral‐procedures/nitrosamine‐impurities“Nitrosamine impurities”

4. USFDA released guidance on “Control of Nitrosamine Impurities in Human Drugs”(last time accessed: February2021).

5. Nitrosamine impurities in human medicinal products 25 June 2020 EMA/369136/2020 Committee for Medicinal Products for Human Use (CHMP).

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