Isolation and characterisation of degradation impurities in the cefazolin sodium drug substance.
Two unknown impurities were detected in the cefazolin sodium bulk drug substance using gradient reversed-phase high-performance liquid chromategraphy (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 (Impurity-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.
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Balasubramanian
B
Sivakumar
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Kannabiran
K
Parthasarathy
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Raman
R
Murugan
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Ramajeyabalan
R
Jeyasudha
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Saravanan
S
Murugan
Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India.
Rajendira Janardhan
RJ
Saranghdar
Cefazolin sodium; Degradation Impurities; LC-MS/MS; NMR; β-Lactam