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Volume 83
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Article

Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium

by
Jagadeesh Kumar VUNDAVILLI
*,
Pavan Kumar S. R. KOTHAPALLI
*,
Badarinadh Gupta PERURI
,
Prasada Rao V. V. KORRAPATI
,
Hemant Kumar SHARMA
and
Sreenivas NALLAPATI
Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India
*
Authors to whom correspondence should be addressed.
Sci. Pharm. 2015, 83(1), 95-106; https://doi.org/10.3797/scipharm.1408-03
Submission received: 4 August 2014 / Accepted: 15 October 2014 / Published: 15 October 2014
Versions Notes

Abstract

A new degradant of Nafcillin Sodium was found at a level of 1.8% w/w during the gradient reversed-phase HPLC analysis in stability storage samples. This impurity was identified by LC-MS and was characterized by 1H-NMR, 13C-NMR, LC/MS/MS, elemental analysis, and IR techniques. Based on the structural elucidation data, this impurity was named as N-[(2S)-2-carboxy-2-{[(2-ethoxy-naphthalen-1-yl)carbonyl]amino}ethylidene]-3-({N-[(2-ethoxynaphthalen-1-yl)-carbonyl]glycyl}sulfanyl)-D-valine. This impurity was prepared by isolation and was co-injected into the HPLC system to confirm the retention time. To the best of our knowledge, this impurity has not been reported elsewhere. The identification and structural elucidation of this degradant impurity has been discussed in detail.
Keywords: Nafcillin Sodium; Stability; Impurities; Characterization Nafcillin Sodium; Stability; Impurities; Characterization

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MDPI and ACS Style

VUNDAVILLI, J.K.; KOTHAPALLI, P.K.S.R.; PERURI, B.G.; KORRAPATI, P.R.V.V.; SHARMA, H.K.; NALLAPATI, S. Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium. Sci. Pharm. 2015, 83, 95-106. https://doi.org/10.3797/scipharm.1408-03

AMA Style

VUNDAVILLI JK, KOTHAPALLI PKSR, PERURI BG, KORRAPATI PRVV, SHARMA HK, NALLAPATI S. Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium. Scientia Pharmaceutica. 2015; 83(1):95-106. https://doi.org/10.3797/scipharm.1408-03

Chicago/Turabian Style

VUNDAVILLI, Jagadeesh Kumar, Pavan Kumar S. R. KOTHAPALLI, Badarinadh Gupta PERURI, Prasada Rao V. V. KORRAPATI, Hemant Kumar SHARMA, and Sreenivas NALLAPATI. 2015. "Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium" Scientia Pharmaceutica 83, no. 1: 95-106. https://doi.org/10.3797/scipharm.1408-03

APA Style

VUNDAVILLI, J. K., KOTHAPALLI, P. K. S. R., PERURI, B. G., KORRAPATI, P. R. V. V., SHARMA, H. K., & NALLAPATI, S. (2015). Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium. Scientia Pharmaceutica, 83(1), 95-106. https://doi.org/10.3797/scipharm.1408-03

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