Abstract

BIOANALYTICAL METHOD VALIDATION FOR PERINDOPRIL AND AMLODIPINE IN HUMAN PLASMA USING UPLC/ESI-MS/MS

Kalaiyarasi D., K. S. Jaganathan* and M. Vamsi Krishna

Abstract

Background: The main objective of this study is to develop and validate a simple mass compatible method for quantification of both perindopril and amlodipine in human plasma. Methods: A UPLC/ESIMS/ MS method for the determination of combined dosage form of perindopril and amlodipine in human plasma sample was developed. The gradient elution with flow rate at 0.3 mL per min of mobile phase was kept and 10 μL of sample was injected in each run. The total chromatographic run time was 5.5 min. Argon was used as the collision gas at the pressure of 3.5X10-5 Torr. Results: In this developed method, a high recovery of perindopril and amlodipine in plasma samples was proved with improved quality data in terms of increased detection limits and chromatographic resolution with greater sensitivity. As per ICH guidelines, the main characteristics of a bioanalytical method validation constraints that are essential to confirm the suitability and reliability of analytical results were evaluated. Conclusion: Quantification of perindopril and amlodipine dosage forms by this method is time saving, cost effective and it can be used in clinical studies from PK studies or clinical trials using LC-MS/MS to quantify the drug content in human plasma samples.

Keywords: Amlodipine, Bioanalytical method, Perindopril, Plasma.