Abstract
A High Performance Liquid Chromatography Mass Spectrometric method for the estimation of Paliperidone in human plasma has been developed and validated using Paliperidone D4 as an internal standard (IS). The extraction of analyte and IS was accomplished by Solid phase Extraction technique. The method has been validated over a concentration range of 0.200 ng/mL to 55.115 ng/mL. Chromatographic separations were achieved using Thermo Betabasic-8, 5 μm 100 mm x 4.6 mm, column eluated at flow rate of 1.0 mL/minute with 1:1 splitted post column with mobile phase Methanol: Ammonium acetate solution (70:30 v/v). The overall run time of method was about 2.8 min. with elution times of paliperidone 1.9 min. The multiple reaction monitoring transitions were set at 427.2 > 207.2 (m/z) and 431.2 > 211.2 (m/z) for paliperidone and paliperidone D4 respectively. The calibration curves were linear (r2 ≥ 0.99) over the range of 0.200-55.00 ng/mL with lower limit of quantitation validated at 0.200 ng/mL. Extraction recoveries were > 99 % for both paliperidone and its stable labeled IS paliperidone D4. The within run and between run precisions were within 101.5 %, while accuracy ranged from 94.2 to 101.4 %.
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