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Synthesis, Analytical Characterization and Spectroscopic Investigation of Chloramphenicol Impurity A for the Quality Control of Chloramphenicol and its Formulation as Per International Compendium

Author(s):

Aparna Wadhwa, Faraat Ali*, Sana Parveen, Robin Kumar and Gyanendra Nath Singh   Pages 1 - 7 ( 7 )

Abstract:


Objective: The main aim of the present work is to synthesize chloramphenicol impurity A (CLRM-IMP-A) in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques (LCMS, DSC, TGA, NMR, FTIR, HPLC and CHNS) to provide as reference standard mentioned in most of the international compendiums including IP, BP, USP, and EP. The present synthetic procedure has not been disclosed anywhere in the prior art.

Method: A simple, cheaper and new synthesis method was described for the preparation of CLRM-IMP-A. It was synthesized and characterized by FTIR, DSC, TGA, NMR (1H and 13C), LC-MS, CHNS, and HPLC.

Results: CLRM-IMP-A present in drugs and dosage form can alter the therapeutic effects and adverse reaction of a drug considerably, it is mandatory to have a precise method for the estimation of impurities to safeguard of the public health. Under these circumstances, the presence of CLRM-IMP-A in chloramphenicol (CLRM) requires strict quality control to satisfy the specified regulatory limit. The synthetic impurity obtained was in pure form to provide a certified reference standard or working standard to stakeholders with defined potency.

Conclusion: The present research describes a novel technique for the synthesis of pharmaceutical impurity which can help in checking/controlling the quality of the CLRM in the international markets.

Keywords:

Chloramphenicol IMP A, Degradation product, LC-MS, NMR, FTIR, DSC, HPLC.

Affiliation:

Pharmaceutical Chemistry Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad, Uttar Pradesh, 201002, Pharmaceutical Chemistry Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad, Uttar Pradesh, 201002, Department of Pharmaceutical Sciences, Raj Kumar Goel Institute of Technology, Delhi-Meerut Road, Ghaziabad, Uttar Pradesh, 201002, Pharmaceutical Chemistry Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad, Uttar Pradesh, 201002, Pharmaceutical Chemistry Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad, Uttar Pradesh, 201002



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