Rahman Mohammad Akhlaquer
Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, Taif, 21974, Kingdom of Saudi Arabia.
MethodsX. 2022 May 31;9:101750. doi: 10.1016/j.mex.2022.101750. eCollection 2022.
The current research aims to develop a rapid, sensitive and robust UPLC-MS/MS method for quantitative estimation of sertraline in rat plasma following oral administration of lipid-based formulation. Different types of isocratic systems were tried for optimization of mobile phase to attain good resolution and appropriate retention time. The multiple reaction monitoring transitions of m/z 306.3 → 159.1 and 515.2 → 276.1 were used to quantify sertraline and internal standard, respectively. The method was validated for different parameters as per the guideline of the United States Food and Drug administration (USFDA). The validated linearity range of sertraline was found to be 1-1,00 ng/mL in rat plasma with 0.1 ng/mL as lower limit of quantification. The intra-day and inter-day precision (RSD%) were within 7.6-10.6% and the accuracies(RE%) were ± 8.0%. The results showed a good percentage recovery of analytes within acceptance limit. No significant degradation of drug in plasma was observed during the stability study. The method demonstrated short analytical run time (< 3 min), low sensitivity (0.1 ng/mL) and requirement of small amount of plasma (50 µL) for extraction procedure. •Results in an optimized and validated assay for estimation of sertraline in plasma.•Offers a cost effective mobile phase with excellent linearity, sensitivity, accuracy, and precision. The method suggested its application in pharmacokinetic study of sertraline administered via oral route.•The method can be used for therapeutic drug monitoring in drug designing. The method can also be used for toxicity and bioequivalence studies.
当前的研究旨在开发一种快速、灵敏且稳健的超高效液相色谱-串联质谱法，用于定量测定大鼠口服脂质体制剂后血浆中的舍曲林。尝试了不同类型的等度洗脱系统来优化流动相，以获得良好的分离度和合适的保留时间。分别采用质荷比（m/z）306.3 → 159.1和515.2 → 276.1的多反应监测跃迁来定量舍曲林和内标。该方法根据美国食品药品监督管理局（USFDA）的指南对不同参数进行了验证。在大鼠血浆中，舍曲林的验证线性范围为1 - 100 ng/mL，定量下限为0.1 ng/mL。日内和日间精密度（相对标准偏差，RSD%）在7.6 - 10.6%范围内，准确度（相对误差，RE%）为±8.0%。结果表明，分析物在可接受限度内具有良好的回收率。在稳定性研究中未观察到血浆中药物有明显降解。该方法分析运行时间短（<3分钟）、灵敏度低（0.1 ng/mL）且提取过程所需血浆量少（50 μL）。•建立了一种优化且经过验证的血浆中舍曲林测定方法。•提供了一种具有出色线性、灵敏度、准确度和精密度的经济高效流动相。该方法表明其可应用于舍曲林口服给药的药代动力学研究。•该方法可用于药物设计中的治疗药物监测。该方法还可用于毒性和生物等效性研究。
