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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2016  >  34(5): 428-430,440

YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012
Citation: YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012
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Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets

doi: 10.3969/j.issn.1006-0111.2016.05.012

  • General Hospital of Ningxia Medical University, Department of Pharmacy, Yinchuan 750004, China;General Hospital of Ningxia Medical University, Division of Clinical pharmacology, Yinchuan 750004, China

  • Received Date: 2015-02-26
  • Rev Recd Date: 2015-06-10
  • Objective To develop a HPLC-fluorescence method to determine levofloxacin concentration in plasma for studying bioequivalence of levofloxacin hydrochloride tablet in Chinese healthy volunteers. Methods A single-dose of 0.2 g test or reference preparation was given to 24 healthy volunteers in a randomized crossover study. The concentrations of levofloxacin at different time points were determined by HPLC with fluorescence detection. The pharmacokinetic parameters were calculated using DAS 2.0 software program. Results The main pharmacokinetic parameters of the test and reference preparation,t 1/2、tmax、ρmax、AUC0-36 and AUC0-inf, were respectively (6.71±0.95) h and (6.60±1.00) h,(0.85±0.30) h and (0.79±0.28) h,(2 815.48±513.04) ng/ml and (3 185.59±674.29) ng/ml,(17 157.61±1 949.07) ng·h/ml and (17 425.06±2 447.80) ng·h/ml,(18 324.52±2 019.41) ng·h/ml and (18 540.41±2 523.08) ng·h/ml. The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences. The 90% confidence interval of test and reference preparations AUC0-36、AUC0-inf and ρmax were 95.2%~102.5%、96.1%~102.2% and 82.8%~94.9%. Conclusion The test and reference preparations were bioequivalent.
  • [1] 郭小瑞,毕开顺,陈晓辉.盐酸左氧氟沙星胶囊的人体生物等效性研究[J]. 中国现代应用药学杂志,2007,24(2):130-132.
    [2] Zhou ZL, Yang M, Yu XY, et al. A rapid and simple high-performance liquid chromatography method for the determination of human plasma levofloxacin concentration andits application to bioequivalence studies[J].Biomed Chromatogr,2007,21(10):1045-1051.
    [3] 钱 妍,赵春景,张桂蓉,等.盐酸左氧氟沙星胶囊的人体生物等效性研究 [J].重庆医科大学学报,2007,32(1):59-62.
    [4] 谢林利,陈勇川,唐 敏,等. 盐酸左氧氟沙星片生物等效性研究[J]. 中国药业,2009,18(16):22-24.
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Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets

doi: 10.3969/j.issn.1006-0111.2016.05.012
  • General Hospital of Ningxia Medical University, Department of Pharmacy, Yinchuan 750004, China;General Hospital of Ningxia Medical University, Division of Clinical pharmacology, Yinchuan 750004, China
  • Received Date: 2015-02-26
  • Rev Recd Date: 2015-06-10

Abstract: Objective To develop a HPLC-fluorescence method to determine levofloxacin concentration in plasma for studying bioequivalence of levofloxacin hydrochloride tablet in Chinese healthy volunteers. Methods A single-dose of 0.2 g test or reference preparation was given to 24 healthy volunteers in a randomized crossover study. The concentrations of levofloxacin at different time points were determined by HPLC with fluorescence detection. The pharmacokinetic parameters were calculated using DAS 2.0 software program. Results The main pharmacokinetic parameters of the test and reference preparation,t 1/2、tmax、ρmax、AUC0-36 and AUC0-inf, were respectively (6.71±0.95) h and (6.60±1.00) h,(0.85±0.30) h and (0.79±0.28) h,(2 815.48±513.04) ng/ml and (3 185.59±674.29) ng/ml,(17 157.61±1 949.07) ng·h/ml and (17 425.06±2 447.80) ng·h/ml,(18 324.52±2 019.41) ng·h/ml and (18 540.41±2 523.08) ng·h/ml. The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences. The 90% confidence interval of test and reference preparations AUC0-36、AUC0-inf and ρmax were 95.2%~102.5%、96.1%~102.2% and 82.8%~94.9%. Conclusion The test and reference preparations were bioequivalent.

YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012
Citation: YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012
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