Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal
Dibya Das1*, Dhiman Halder2, Himangshu Sekhar Maji1, Pintu Kumar De1, Tapan Kumar Pal2
1Department of Pharmaceutical Technology, JIS University, Kolkata.
2Department of Pharmaceutical Technology, Bioequivalence Study Centre, Jadavpur University, Kolkata.
Volume - 14,
Issue - 7,
Year - 2021
The aim of this study is to develop and validate an accurate, sensitive, rapid, precise, and simple bioanalytical method for the estimation of Azelnidipine (calcium channel blocker, used in hypertension) in the human plasma by using LC-ESI-MS/MS. The method was developed by gradient conditions using 0.1% Formic Acid in Acetonitrile and Milli-Q water with 10mM Ammonium acetate as a mobile phase with a flow rate of 0.5 mL/min. The Analyte and IS (Metoprolol) were separated by using a C18 Phenomenex Kinetex (50x3mm, 5µ) column. 7.0 minutes was the chromatographic run time. The analyte and IS extracted from plasma by simple protein precipitation technique (PPT). The LOD and LLOQ were found to be 0.53125ng/mL and 1.0625ng/mL, respectively. The extraction recovery of the drug from plasma was high. The other validation parameters were found within the range, as mentioned by USFDA and EMA guidelines.
Cite this article:
Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal. Special Emphasis on Bioanalytical Method Development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma. Research Journal of Pharmacy and Technology. 2021; 14(7):3571-7. doi: 10.52711/0974-360X.2021.00618
Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal. Special Emphasis on Bioanalytical Method Development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma. Research Journal of Pharmacy and Technology. 2021; 14(7):3571-7. doi: 10.52711/0974-360X.2021.00618 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-7-15
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