Celina NazarethPES’s Rajaram and Tarabai Bandekar College of Pharmacy, India
Title: A novel LC-MS/MS method for the estimation of antispasmodic agent in human plasma using deuterated internal standard
Method development is an integral part of drug development process. Bioanalysis plays a significant role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic and toxicokinetic studies. Bioanalytical methods employing LC-MS/MS allow the analyte of interest in highly complex mixtures to be isolated and measured. Baclofen is a skeletal muscle relaxant used to treat pain and certain types of spasticity from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. A simple and a rapid LC-MS/MS method has been developed and validated for the estimation of baclofen in human plasma using baclofen D4 as an internal standard. The analysis was performed on Shimadzu HPLC combined with Applied Biosystems API 4000 mass spectrometer using turbo spray ionisation mode. Sample preparation was accomplished by solid phase extraction technique. Chromatography was carried on Hypurity C18 column, 100x4.6mm, 5µ using a mobile phase consisting of acetonitrile: 10 mM ammonium acetate (80:20 v/v). Baclofen and baclofen D4 eluted at 1.50 min (±0.50 min) with an overall run time of 3 minutes. Linearity was established over a concentration range of 1.018 to 504.12 ng/ml for baclofen. The method was validated as per EMA guidelines and the results were found to be within acceptable limits.
Celina Nazareth completed her B.Pharm. and M.Pharm. from Goa College of Pharmacy, Goa and Ph.D. from JNTU, Hyderabad, India. With vast teaching experience of 25 years, she has been teaching in PES’s Rajaram and Tarabai Bandekar College of Pharmacy, Farmagudi, Goa, India in the Department of Pharmaceutical Chemistry with specialization in Pharmaceutical Analysis. She has 20 publications and has participated in many National and International Conferences.