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| Asian Journal of Pharmaceutical Sciences 2009, 4(4): 228-233 ISSN: 1818-0876 CN: |
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Determination of bismuth in human plasma by inductively coupled
plasma-mass spectrometry and its use in bioequivalence studies
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Jian Shi1, Xueya Wang2, Peng Zhang1, Hongmin Zhu1, Huaiqing Zhao1*
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1 School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
2 Vocational and Technical College, Liaoning University of Traditional Chinese Medicine, Shenyang, China
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Received
2009-3-5
; Revised
2009-5-12
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Accepted
2009-7-6
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Online
2009-9-10
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Abstract
Purpose:  To evaluate the pharmacokinetics and bioequivalence of bismuth from two compound preparations. Methods: This was an open randomized, two period cross-over study on twenty healthy male volunteers. The bismuth concentrations in plasma after an oral dose of the test or reference products (equivalent to 110 mg bismuth) were determined by inductively coupled plasma-mass spectrometry (ICP-MS). A non-compartmental method was used for calculation of the pharmacokinetic parameters. Logarithm-transformed Cmax and AUC
were analyzed by analysis of variance (ANOVA) and 90% confidence intervals were calculated. Results: The main pharmacokinetics parameters of bismuth from test and reference drug were as follows: Cmax (36.27±21.80), (35.07±22.84) ng/ml, tmax (0.73±0.31), (0.76±0.36) h, AUC0-24 (135.9±82.7), (133.8±85.7) ng·h/ml, AUC0-∞ (161.7±99.1), (157.4±101.5) ng·h/ml, and t1/2 (10.92±3.10), (11.04±3.14) h, respectively. Conclusion: It was concluded that the two compound preparations are bioequivalent with regard to bismuth.
Keywords:
Bismuth
Compound preparation
ICP-MS
Pharmacokinetics
Bioequivalence
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