Next Article in Journal
Simultaneous Determination and Pharmacokinetic Study of Losartan, Losartan Carboxylic Acid, Ramipril, Ramiprilat, and Hydrochlorothiazide in Rat Plasma by a Liquid Chromatography/Tandem Mass Spectrometry Method
Previous Article in Journal
A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2015, 83(1), 95-106; doi:10.3797/scipharm.1408-03

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
*
Authors to whom correspondence should be addressed.
Received: 4 August 2014 / Accepted: 15 October 2014 / Published: 15 October 2014
Download PDF [252 KB, uploaded 6 September 2016]

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).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

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.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top