Identification and characterization of degradation products of Nateglinide

Pratima Kumari; Ritchu Babbar; Ravinder Singh; Balraj Saini

doi:10.53730/ijhs.v6nS2.8413

Identification and characterization of degradation products of Nateglinide

https://doi.org/10.53730/ijhs.v6nS2.8413

Authors

Pratima Kumari Chitkara College of Pharmacy, Chitkara University, Rajpura- 140401, India
Ritchu Babbar Chitkara College of Pharmacy, Chitkara University, Rajpura- 140401, India
Ravinder Singh Chitkara College of Pharmacy, Chitkara University, Rajpura- 140401, India
Balraj Saini
balraj.saini@chitkara.edu.in
Chitkara College of Pharmacy, Chitkara University, Rajpura- 140401, India

Keywords:

nateglinide, LC-MS-QTOF, forced degradation, mass fragmentation, impurities

Abstract

Nateglinide (NTG) was evaluated under a variety of ICH-recommended forced degradation settings and found to be degraded under acid and alkali hydrolysis but stable under other forced degradation conditions. Under acid hydrolytic conditions, three degradation impurities (I-III) were produced. All three contaminants were separated using a C-18 column with ammonium acetate buffer (20 mM), methanol, and acetonitrile as mobile phases provided in isocratic mode, and characterisation was done utilising +ESI-MSn and LC-MS-QTOF investigations. All three degrading impurities (I-III) were discovered to be novel. The most likely pathways of deterioration were presented and debated.

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References

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Published

04-06-2022

How to Cite

Kumari, P., Babbar, R., Singh, R., & Saini, B. (2022). Identification and characterization of degradation products of Nateglinide. International Journal of Health Sciences, 6(S2), 12894–12904. https://doi.org/10.53730/ijhs.v6nS2.8413

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Issue

Vol. 6 No. S2 (2022)

Section

Peer Review Articles

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