Application of a high performance liquid chromatography-tandem mass spectrometry method for determination of buflomedil in human plasma for a bioequivalence study.
A rapid, simple and sensitive method based on ultra fast liquid chromatography-tandem spectrometry for the determination of buflomedil in human plasma has been developed and validated using carbamazepine as internal standard. After the precipitation of plasma sample with methanol, the analyte and IS were separated on an Ultimate C18 column (5μm, 2.1mm×50mm, MD, USA) with an isocratic mobile phase composed of acetonitrile and 5mM ammonium acetate in water (60:40, v/v) at a flow rate of 0.25ml/min. The analyte and IS were detected with proton adducts at m/z 308.3-237.1 and m/z 237.2-194.2 in positive ion electrospray ionization and multiple reaction monitoring acquisition mode, respectively. The lower limit of quantification of the method was 23.64ng/ml with a linear dynamic range of 23.64-1182ng/ml for buflomedil. The intra- and inter-batch precisions were less than 5.8%. The developed method was successfully applied to a bioequivalence study of two buflomedil hydrochloride preparations (150mg) in 22 healthy Chinese male volunteers.
College of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Li
L
Ren
Chun
C
Yang
Yan
Y
Peng
Fan
F
Li
Ying-Hui
YH
Li
Heng
H
Zheng
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018592:Cross-Over Studies; D004355:Drug Stability; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D011759:Pyrrolidines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
D011759:Pyrrolidines; C010651:buflomedil
Bioequivalence; Buflomedil; LC–MS/MS