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Volume 81
Issue 4
10.3797/scipharm.1304-14
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Article

Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance

by
Balasubramanian SIVAKUMAR
*,
Kannabiran PARTHASARATHY
,
Raman MURUGAN
,
Ramajeyabalan JEYASUDHA
,
Saravanan MURUGAN
and
Rajendira JANARDHAN SARANGHDAR
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2013, 81(4), 933-950; https://doi.org/10.3797/scipharm.1304-14
Submission received: 15 April 2013 / Accepted: 4 June 2013 / Published: 4 June 2013
Versions Notes

Abstract

Two unknown impurities were detected in the cefazolin sodium bulk drug substance using gradient reversed-phase high-performance liquid chromate-graphy (HPLC). These impurities were isolated by preparative HPLC and characterized by using spectroscopic techniques like LC-MS, LC-MS/MS, 1D, 2D NMR, and FT-IR. Based on the spectral data, the impurities have been characterized as N-(2,2-dihydroxyethyl)-2-(1H-tetrazol-1-yl)acetamide (Impu rity-I) and 2-{carboxy[(1H-tetrazol-1-ylacetyl)amino]methyl}-5-methylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (Impurity-II). The structures of these impurities were also established unambiguously by co-injection into HPLC to confirm the retention time. To the best of our knowledge, these two impurities were not reported elsewhere.
Keywords: Cefazolin sodium; Degradation Impurities; LC-MS/MS; NMR; β-Lactam Cefazolin sodium; Degradation Impurities; LC-MS/MS; NMR; β-Lactam

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MDPI and ACS Style

SIVAKUMAR, B.; PARTHASARATHY, K.; MURUGAN, R.; JEYASUDHA, R.; MURUGAN, S.; SARANGHDAR, R.J. Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance. Sci. Pharm. 2013, 81, 933-950. https://doi.org/10.3797/scipharm.1304-14

AMA Style

SIVAKUMAR B, PARTHASARATHY K, MURUGAN R, JEYASUDHA R, MURUGAN S, SARANGHDAR RJ. Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance. Scientia Pharmaceutica. 2013; 81(4):933-950. https://doi.org/10.3797/scipharm.1304-14

Chicago/Turabian Style

SIVAKUMAR, Balasubramanian, Kannabiran PARTHASARATHY, Raman MURUGAN, Ramajeyabalan JEYASUDHA, Saravanan MURUGAN, and Rajendira JANARDHAN SARANGHDAR. 2013. "Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance" Scientia Pharmaceutica 81, no. 4: 933-950. https://doi.org/10.3797/scipharm.1304-14

APA Style

SIVAKUMAR, B., PARTHASARATHY, K., MURUGAN, R., JEYASUDHA, R., MURUGAN, S., & SARANGHDAR, R. J. (2013). Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance. Scientia Pharmaceutica, 81(4), 933-950. https://doi.org/10.3797/scipharm.1304-14

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