Document Type : Full research article

Authors

• Sibaprasad Sahoo ¹
• Nisarg H. Desai ¹
• Anil Bhatt ¹
• K. Shivramchandra ¹
• B.V. Kamath ²

¹ Sun Pharmaceutical Indusrties Ltd, Tandalja, Vadodara-390020, India

² Institute of Infrastructure, Technology, Research and Management, Ahmedabad-380008, India

Abstract

A rapid, specific and accurate proton quantitative Nuclear Magnetic Resonance spectroscopic (¹H qNMR) and also a reversed phase derivatization HPLC method have been developed to quantify a toxic, UV-visible inactive and non-volatile impurity N,N-Dimethylamine hydrochloride (DMA∙HCl) in Metformin Hydrochloride (MF∙HCl), an Active Pharmaceutical Ingradient. The method is based on proton quantitative NMR spectroscopy (¹H qNMR) using Glycine as internal standard and deuterium oxide (D₂O) as diluent. Both the methods have been validated as per the parameters of ICH guidelines and are found to be comparable.The advantages of the proposed ¹H qNMR method are that no certified reference standard of DMA∙HCl is required for quantification, the method is specific, non-destructive and can be applied for quantification of DMA∙HCl in process, quality control for the manufacturing of Metformin hydrochloride as well as commercial dosage form products.

Keywords

• Metformin Hydrochloride
• N,N-Dimethylamine Hydrochloride
• Glycine
• 1H qNMR Spectroscopy