Determination of sinomenine sustained-release capsules in healthy Chinese volunteers by liquid chromatography–tandem mass spectrometry
| Autor: | Aidong Wen, Min Song, Zhong-Nan Xu, Mengxiang Su, Hua Zhao, De-Zhu Sun, Xiao-Le Zhan, Taijun Hang, Ling Zhu, Xiao Gu |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male China Clinical Biochemistry Sensitivity and Specificity Biochemistry Analytical Chemistry chemistry.chemical_compound Drug Stability Pharmacokinetics Tandem Mass Spectrometry Liquid chromatography–mass spectrometry Oral administration Humans Least-Squares Analysis Sinomenine Chromatography Chemistry Elution Selected reaction monitoring Reproducibility of Results Cell Biology General Medicine Morphinans Linear range Area Under Curve Delayed-Action Preparations Ammonium acetate Chromatography Liquid |
| Zdroj: | Journal of Chromatography B. :39-43 |
| ISSN: | 1570-0232 |
| DOI: | 10.1016/j.jchromb.2012.01.027 |
| Popis: | 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 were 4.4±3.6 h, 279±69 ng/mL, 7333±2096 ng h/mL and 15.1±1.3 h, respectively. The AUC and C(max) values after multiple-dose treatment were significantly higher than those after a single-dose treatment (P |
| Databáze: | OpenAIRE |
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