Development and Validation of a HPLC-based Bioanalytical Method for Lorcaserin using Solid Phase Extraction and Application to a Pharmacokinetic Study in Rats
Department of Pharmaceutical Quality Assurance, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara-390 002, India
Department of Pharmaceutical Quality Assurance, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara-390 002, India, E-mail: firstname.lastname@example.org
A rapid, precise, accurate, specific and simple high performance liquid chromatography method for estimation of lorcaserin hydrochloric in human plasma, using metoprolol as an internal standard, was developed and validated as per the regulatory requirements. Sample preparation included solid phase extraction and chromatographic separation was performed using a Phenomenex Luna C18 column (250×4.6 mm i.d, 5 µ particle size), with phosphate buffer (pH 3):acetonitrile:methanol (65:20:15) as the mobile phase at a flow rate of 1.0 ml/min. Wavelength of detection was 222 nm. Retention times of internal standard and lorcaserin HCl were found to be 5.15 and 7.19 min, respectively. The method was developed and tested in the linearity range of 500 to 3000 ng/ml. The method was validated for accuracy, precision, linearity, recovery and stability in compliance to international regulatory guidelines.