title: Determination of butenafine hydrochloride in human plasma by liquid chromatography electrospray ionization-mass spectrometry following its topical administration in human subjects.
abstract: An HPLC/MS/MS method for determination of butenafine hydrochloride in human plasma with testosterone propionate as the internal standard (IS) was developed and validated. Plasma samples were extracted with an n-hexane/diethyl ether (1:2, v/v) mixture and separated using a C(18) column by a gradient elution with the mobile phase containing acetonitrile and 5mM ammonium acetate buffer. Quantification was performed using multiple reaction monitoring (MRM) mode with transition of m/z 318.4→141.0 for butenafine hydrochloride and m/z 345.5→97.0 for testosterone propionate (IS). This method was validated in terms of specificity, linearity, precision, accuracy, and stability. The lower limit of quantification (LLOQ) of this method was 0.0182 ng/ml and the calibration curve was linear over the 0.0182-1.82 ng/ml. The intra- and inter-run coefficient of variance was less than 11.53% and 10.07%, respectively. The samples were stable under all the tested conditions. The method was successfully applied to study the pharmacokinetics of butenafine hydrochloride in healthy Chinese volunteers following its topical administration.
authors: Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China.
authors: Lin
authors: L
authors: Song
authors: Xuehua
authors: X
authors: Jiang
authors: Ling
authors: L
authors: Wang
mesh_terms: D000287:Administration, Topical; D000328:Adult; D019540:Area Under Curve; D001596:Benzylamines / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D043343:Testosterone Propionate
chemical_list: D001596:Benzylamines; D009281:Naphthalenes; C067594:butenafine; D043343:Testosterone Propionate