Simple, sensitive and rapid liquid chromatography/atmospheric pressure chemical ionization mass spectrometric method for the quantitation of Ranolazine in rat plasma.
A sensitive and specific method using liquid chromatography with atmospheric pressure chemical ionization mass spectrometry (LC/APCI-MS) has been developed and validated for the identification and quantification of Ranolazine in rat plasma. A simple liquid-liquid extraction procedure was followed by injection of the extracts onto a C18 column with isocratic elution and detection using a single quadrupole mass spectrometer in selected ion monitoring (SIM) mode. The method was tested using six different batches of blank plasma. Linearity was established for the concentration range 0.02-10.0 microg/mL, with a coefficient of determination (r) of 0.9998 and good back-calculated accuracy and precision. The intra- and inter-day precision (relative standard deviation (RSD) %) was lower than 10%, and accuracy ranged from 85 to 115%. The lower limit of quantification was reproducible at 0.01 microg/mL with 20 microL plasma. The proposed method enables the unambiguous identification and quantification of Ranolazine for pre-clinical and clinical studies.
Liang
Yan
Y
Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, PR China.
Xie
Lin
L
Liu
Xiao-Dong
XD
Chen
Wei-Dong
WD
Lu
Tong
T
Xiong
Ye
Y
Wang
Guang-Ji
GJ
D000083:Acetanilides; D000284:Administration, Oral; D000818:Animals; D002138:Calibration; D005260:Female; D008297:Male; D013058:Mass Spectrometry / Q000379:methods*; D015394:Molecular Structure; D010879:Piperazines / Q000008:administration & dosage / Q000097:blood*; D000069458:Ranolazine; D051381:Rats; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000083:Acetanilides; D010879:Piperazines; D000069458:Ranolazine