H-M Lu

Shanghai Jiao Tong University, Shanghai, Shanghai Shi, China

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Publications (2)1.4 Total impact

  • H-M Lu · M Ye
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    ABSTRACT: A simple LC-MS/MS method was developed for determination and pharmacokinetic study of Epothilone B in rat plasma.Plasma sample pretreatment involved a one-step liquid-liquid extraction of 100 µL plasma. The chromatographic separation was carried out on a Agilent Zobax SB C18 column with a mobile phase consisting of 10 mmol/L ammonium acetate-acetonitrile (35:65, v/v) at a flow rate of 0.2 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by SRM via electro spray ionization source with positive mode.The standard curve for Epothilone B was linear over the concentration range of 1-100 ng/mL with a lower limit of quantification of 0.5 ng/mL. The intra- and inter-day precision (relative standard deviation) values were not higher than 15% and the accuracy (relative error) was < 10% at 3 quality control levels. Pharmacokinetic parameters were as follows: t1/2, 3.56 (1.12) h; AUC0-24 h, 295.7 (65.3) ng · h/mL and AUC0-∞, 339.2 (87.4) ng · h/mL, CL, 5.77 (0.67) mL/h; MRT, 7.55 (2.41) h, respectively.This simple, fast and highly sensitive method was fully validated and successfully applied to a preclinical pharmacokinetic study of Epothilone B in rats after i. v. administration.
    No preview · Article · Oct 2012 · Arzneimittel-Forschung
  • H-M Lu · M Ye
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    ABSTRACT: The aim of this study was to evaluate the bioequivalence of a new generic formulation of bicalutamide 50-mg tablets (test) and the available branded formulation (reference) to comply with regulatory criteria for marketing of the test product in China. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in 40 healthy male volunteers and consisted of separate fasting and fed phases. A single oral dose of the test or reference formulation was followed by a 6-week washout period, after which subjects received the alternative formulation. Blood samples were collected before dosing and at 0.5, 1, 2, 4, 8, 12, 15, 24, 30, 36, 48, 72, 144, 288, 432 and 576 h after dosing. Plasma samples were separated and assayed for bicalutamide using a selective and sensitive HPLC method with UV detection. The fasting and fed states pharmacokinetic parameters AUC0-576 h, AUC0-∞, Cmax, tmax and t1/2 were determined from plasma concentration-time profile of both formulations. The formulations were considered bioequivalent when the 90% CIs of the geometric mean ratios (test:reference) for Cmax and AUC0-576 h were within the regulatory range of 80-125%. There were no significant increases in bicalutamide Cmax, AUC0-576 h or tmax for either formulation in the fed phase compared with the fasting phase. In both the fasting and fed portions of the study, the 90% CIs for the ratio (test:reference) of log-transformed Cmax and AUC0-576 h were within the acceptance range for bioequivalence.
    No preview · Article · Jan 2012 · Arzneimittel-Forschung

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2 Citations
1.40 Total Impact Points

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  • 2012
    • Shanghai Jiao Tong University
      Shanghai, Shanghai Shi, China
    • Shandong Jiaotong University
      Chi-nan-shih, Shandong Sheng, China