VALIDATED UFLC-MS/MS METHOD FOR THE QUANTITATIVE ESTIMATION OF PALIPERIDONE IN RABBIT PLASMA; ADAPTABILITY TO IN-VIVO BIOAVAILABILITY STUDYAbstract
A simple gradient ultrafast liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative estimation of paliperidone in rabbit plasma matrix as per USFDA, and EMA guidelines using a stable isotope-labeled paliperidone-d4 was added as an internal standard. The separation was achieved on a Hypersil BDS C18 column (4.6 mm × 10 cm, 5 µm) with the mobile phase composition of 5 mM ammonium formate in HPLC grade water with 0.05% formic acid (Mobile phase A) and acetonitrile with 0.05% formic acid (Mobile phase B) at a flow rate 1 ml/min in gradient mode. A simple single-step protein precipitation extraction method was adapted using acetonitrile. Quantification of analyte was achieved using positive ionization. Mass ion transitions used were 427.0→207.0 for paliperidone and 431.1→211.0 for paliperidone-d4. The linearity curve was obtained, found to be linear, and the regression coefficient was 0.9990 in the concentration range of 0.25-250 ng/ml. The ruggedness and accuracy of all levels of QC were ranged from 0.81 to 6.02% and 94.22 to 104.40%, respectively. The stability study showed that both paliperidone and IS were stable. The novel method developed during the study was specific, precise, and accurate. Hence, this method would be adapted for estimating paliperidone from marketed tablets after oral administration in rabbits.
R. Sadashivaiah and B. K. Satheeshababu *
Department of Pharmaceutics, Government College of Pharmacy, #2, P. Kalingarao Road, Subbaiah Circle, Bengaluru, Karnataka, India.
11 November 2020
06 May 2021
27 May 2021
01 December 2021