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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2015). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Sci. Pharm. 2015, 83(1), 95-106; https://doi.org/10.3797/scipharm.1408-03 (registering DOI)

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

Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India
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Authors to whom correspondence should be addressed.
Received: 4 August 2014 / Accepted: 15 October 2014 / Published: 15 October 2014
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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
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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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.

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