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

نویسندگان

  • Balasubramanian Sivakumar
  • Kannabiran Parthasarathy
  • Raman Murugan
  • Ramajeyabalan Jeyasudha
  • Saravanan Murugan
  • Rajendira Janardhan Saranghdar
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Embryo and Developmental Toxicity of Cefazolin Sodium Impurities in Zebrafish

Cefazolin sodium is an essential drug that is widely used in clinical therapy for certain infective diseases caused by bacteria. As drug impurities are considered to be one of the most important causes of drug safety issues, we studied embryotoxicity, cardiotoxicity, and neurotoxicity of nine cefazolin sodium impurities in zebrafish embryo and larvae for the objective control of impurity profil...

متن کامل

Determination of Synthetic Precursors as Impurities in Diclofenac Sodium Raw Material

Impurities of drug substances may produce some side effects in patient. Diclofenac Na is a member of non-steroidal anti inflammatory drugs (NSAIDs) family, which is routinely used by patients for the treatment of rheumatoid arthritis and various pains. To develop a method for the determination of synthetic precursors which could be remained as impurities in raw drug materials, Na diclofenac pow...

متن کامل

Determination of Synthetic Precursors as Impurities in Diclofenac Sodium Raw Material

Impurities of drug substances may produce some side effects in patient. Diclofenac Na is a member of non-steroidal anti inflammatory drugs (NSAIDs) family, which is routinely used by patients for the treatment of rheumatoid arthritis and various pains. To develop a method for the determination of synthetic precursors which could be remained as impurities in raw drug materials, Na diclofenac pow...

متن کامل

Isolation and Identification of Process Related Impurities and Degradation Products from Pharmaceutical Drug Candidates, Part I

The objective of this two-part review article is to provide guidance for isolating and identifying process related impurities and degradation products from pharmaceutical drug candidates. The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development...

متن کامل

Stability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection

In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chroma...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 81  شماره 

صفحات  -

تاریخ انتشار 2013