Determination of sinomenine sustained-release capsules in healthy Chinese volunteers by liquid chromatography-tandem mass spectrometry

Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Meng-Xiang SuTai-jun Hang

Abstract

A sensitive and selective liquid chromatographic tandem mass spectrometric method was developed and validated for the determination of sinomenine in human plasma. Plasma samples were precipitated using methanol with metronidazole as internal standard. Separation was carried out on an Inertsil ODS-3 column using a mixture of 0.2% ammonium acetate solution (A) and methanol (B) as the mobile phase with linear gradient elution as follows: 0 min (50%B)→1.5 min (80%B)→4.5 min (80%B)→4.6 min (50%B)→6.0 min (50%B). All mass data were obtained in the positive ion mode, and the fragmentation transitions for the selective multiple reaction monitoring were m/z 330→181 and 172→128 for sinomenine and metronidazole, respectively. The method was fully validated to be accurate and precise with a linear range of 0.5-500 ng/mL and applied to a single- and multiple-dose pharmacokinetics study of sustained-release capsules of sinomenine hydrochloride in 20 healthy Chinese volunteers. After oral administration of a single 60-mg dose, the T(max), C(max), AUC(0-96) and t(1/2) were 7.9±2.0h, 123±22 ng/mL, 3032±682 ng h/mL and 13.4±1.6 h, respectively. After oral administration of the 60 mg capsules twice-daily for 7 consecutive days, these parameters w...Continue Reading

References

Oct 30, 2007·Autoimmunity·H FengS Yoshino
Aug 6, 2010·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Xiao-dong JuYue-lin Hu

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Citations

Apr 29, 2014·Journal of Ethnopharmacology·Camille DesgrouasEvelyne Ollivier
Dec 15, 2015·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Kegang Wu, Suqin Han

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