Development of UPLC-MS/MS method and its pharmacokinetic application for estimation of sertraline in rat plasma

MethodsX

Mohammad Akhlaquer Rahman¹ 

[1] Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, Taif, 21974, Kingdom of Saudi Arabia;

关键词: Development;    Validation;    Robustness;    Pharmacokinetic application;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.Overall, this method • 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.

【 授权许可】

Unknown