中国药房2011，Vol.22Issue(42)：3975-3978,4.
LC-MS法同时测定厄贝沙坦氢氯噻嗪片中2组分的血药浓度及其生物等效性研究
Simultaneous Determination of Plasma Concentrations of 2 Components of lrbesartan Hydrochlorothiazide Tablet and Bioequivalence Study of It
华雯妍 1黄明 1王蒙 1施爱明 1周文佳 1张全英1
作者信息
- 1. 苏州大学附属第二医院临床药理实验室,苏州市215004
- 折叠
摘要
Abstract
OBJECTIVE: To develop the simultaneous determination method of irbesartan and hydrochlorothiazide in human plasma, and to evaluate the bioequivalence of 2 kinds of Irbesartan hydrochlorothiazide tablets. METHODS: Telmisartan was used as the internal standard. Plasma sample was extracted with acetonitrile and centrifuged. LC-MS/MS method was adopted and the determination was performed on Waters Xterra RP18(150 mm×4.6 mm, 5 μm)column with acetonitrile-1 mmol·L-1 ammonium acetate buffer solution (pH adjusted to 9.0 using ammonia water) (35:65) as mobile phase. Mass charge ratio of ion pair irbesartan was m/z - 427.3→ -193.0 and that of hydrochlorothiazide was m/z -296.0→ -122.9. The bioequivalence of test preparation and reference preparation of Irbesartan hydrochlorothiazide tablets in 18 healthy volunteers after oral administration were investigated in randomized double-cycle cross-over design. RESULTS: The linear ranges were 2.00～5 000 μg·L-1 for irbesartan(r=0.998 4)and 2.00～200 μg·L-1 for hydrochlorothiazide (r=0.998 8). The lowest limits of quantization were 2.00 μg·L-1. The recovery rate was above 90%, and the intra-day and inter-day RSDs were both less than 10%. The recoveries of irbesartan ranged 96.3% ～ 108.0% , and that of hydrochlorothiazide ranged 98.2%～100.5%. There were no significant difference in cmax, AUC0-1, AUCV-. Between two preparation and cycles (P>0.05). There was no significant differenc in tmax, between two preparations in non-parameter test (P>0.05). CONCLUSION: The method is simple in pretreatment and is specific, rapid, and accurate in analysis. The method can simultaneously deter-mine plasma concentration of irbesartan and hydrochlorothiazide quantitatively. Two preparations are bioequivalent.关键词
厄贝沙坦/氢氯噻嗪/血药浓度/液-质联用法/生物等效性Key words
Irbesartan/ Hydrochlorothiazide/ Plasma concentration/ LC-MS/ Bioequivalence分类
医药卫生引用本文复制引用
华雯妍,黄明,王蒙,施爱明,周文佳,张全英..LC-MS法同时测定厄贝沙坦氢氯噻嗪片中2组分的血药浓度及其生物等效性研究[J].中国药房,2011,22(42):3975-3978,4.
