Abstract：
UNASSIGNED: The study aimed to develop a rapid, simple and sensitive LC/ESI-MS/MS method to measure prazosin concentration in human plasma and apply bedside sampling in bioequivalence study of two prazosin tablets to resolve the adverse effect of orthostatic hypotension.
UNASSIGNED: The LC/ESI-MS/MS prazosin method was highly sensitive and selective. Bedside sampling reduced the orthostatic hypotension incidence and subject dropout rate.
UNASSIGNED: After sample preparation, prazosin and terazosin (IS) were detected on mass spectrometer operating in multiple reaction monitoring mode using positive ionization. Mobile phase flow rate was set at 0.40 mL/min with sample run time of 1.75 min. The bioanalytical method was validated as per EMEA and FDA guidelines. Bedside sampling was performed in bioequivalence study for the first 4 h after dosing. The three primary pharmacokinetic parameters, Cmax, AUC0-t and AUC0-∞ and 90% confidence interval were determined.
UNASSIGNED: The small injection volume of 1 μL minimized instrumentation contamination and prolonged the analytical column lifespan. Linearity was obtained between 0.5 and 30.0 ng/mL, with coefficient of determination, r2 ≥ 0.99. The mean extraction recovery of prazosin and IS was >92%, with precision value (CV, %) ≤ 10.3%. Only two orthostatic hypotension adverse events were reported. The two prazosin formulations were found to be bioequivalent.
UNASSIGNED: The LC/ESI-MS/MS method has shown robustness and reliability exemplified by the incurred sample re-analysis result. Bedside sampling should be proposed for bioequivalence or pharmacokinetic studies of drugs demonstrating adverse event of orthostatic hypotension.
UNASSIGNED: The LC/ESI-MS/MS prazosin method was highly sensitive and selective. Bedside sampling reduced the orthostatic hypotension incidence and subject dropout rate.
UNASSIGNED: After sample preparation, prazosin and terazosin (IS) were detected on mass spectrometer operating in multiple reaction monitoring mode using positive ionization. Mobile phase flow rate was set at 0.40 mL/min with sample run time of 1.75 min. The bioanalytical method was validated as per EMEA and FDA guidelines. Bedside sampling was performed in bioequivalence study for the first 4 h after dosing. The three primary pharmacokinetic parameters, Cmax, AUC0-t and AUC0-∞ and 90% confidence interval were determined.
UNASSIGNED: The small injection volume of 1 μL minimized instrumentation contamination and prolonged the analytical column lifespan. Linearity was obtained between 0.5 and 30.0 ng/mL, with coefficient of determination, r2 ≥ 0.99. The mean extraction recovery of prazosin and IS was >92%, with precision value (CV, %) ≤ 10.3%. Only two orthostatic hypotension adverse events were reported. The two prazosin formulations were found to be bioequivalent.
UNASSIGNED: The LC/ESI-MS/MS method has shown robustness and reliability exemplified by the incurred sample re-analysis result. Bedside sampling should be proposed for bioequivalence or pharmacokinetic studies of drugs demonstrating adverse event of orthostatic hypotension.
摘要：
未经评估：该研究旨在开发一种快速，简单、灵敏的LC/ESI-MS/MS法测定人血浆中哌唑嗪的浓度，并应用床旁取样进行两种哌唑嗪片的生物等效性研究，以解决直立性低血压的不良反应。
UNASSIGNED：LC/ESI-MS/MS哌唑嗪方法灵敏度高，选择性高。床旁采样降低了体位性低血压的发生率和受试者的辍学率。
未经评估：样品制备后，哌唑嗪和特拉唑嗪（IS）在多反应监测模式下使用正电离的质谱仪上检测。流动相流速设定为0.40mL/min,样品运行时间为1.75min。生物分析方法根据EMEA和FDA指南进行验证。在给药后的前4小时，在生物等效性研究中进行床边采样。三个主要的药代动力学参数，Cmax,确定AUC0-t和AUC0-∞和90%置信区间。
UNASSIGNED：1μL的小进样体积最大程度地减少了仪器污染，并延长了分析柱的使用寿命。线性在0.5和30.0ng/mL之间，带有决定系数，r2≥0.99。哌唑嗪和IS的平均提取回收率>92%，具有精度值(CV，%)≤10.3%。仅报告了两个直立性低血压不良事件。发现两种哌唑嗪制剂是生物等效的。
UNASSIGNED：LC/ESI-MS/MS方法已显示出稳健性和可靠性，例如所产生的样品再分析结果。应建议进行床边采样，以进行生物等效性或药代动力学研究，以证明存在直立性低血压的不良事件。
UNASSIGNED：LC/ESI-MS/MS哌唑嗪方法灵敏度高，选择性高。床旁采样降低了体位性低血压的发生率和受试者的辍学率。
未经评估：样品制备后，哌唑嗪和特拉唑嗪（IS）在多反应监测模式下使用正电离的质谱仪上检测。流动相流速设定为0.40mL/min,样品运行时间为1.75min。生物分析方法根据EMEA和FDA指南进行验证。在给药后的前4小时，在生物等效性研究中进行床边采样。三个主要的药代动力学参数，Cmax,确定AUC0-t和AUC0-∞和90%置信区间。
UNASSIGNED：1μL的小进样体积最大程度地减少了仪器污染，并延长了分析柱的使用寿命。线性在0.5和30.0ng/mL之间，带有决定系数，r2≥0.99。哌唑嗪和IS的平均提取回收率>92%，具有精度值(CV，%)≤10.3%。仅报告了两个直立性低血压不良事件。发现两种哌唑嗪制剂是生物等效的。
UNASSIGNED：LC/ESI-MS/MS方法已显示出稳健性和可靠性，例如所产生的样品再分析结果。应建议进行床边采样，以进行生物等效性或药代动力学研究，以证明存在直立性低血压的不良事件。
