Open AccessBIO ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF EZETIMIBE AND PITAVASTATIN AND ITS APPLICATION TO PHARMACOKINETIC STUDIES USING UPLC
Author(s) -
S. Prasanthi,
Himabindu Gandham
Publication year - 2022
Publication title -
ymer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.103
H-Index - 5
ISSN - 0044-0477
DOI - 10.37896/ymer21.02/67
Subject(s) - chromatography , ezetimibe , pitavastatin , analyte , formic acid , calibration curve , chemistry , pharmacokinetics , detection limit , statin , pharmacology , medicine , biochemistry
A simple, sensitive and rapid UPLC method was developed and validated for the simultaneous quantification of Ezetimibe and Pitavastatin. Separation was carried on C18 column (50x2.1mm, 1.7µ) using a isocratic elution with a buffer containing 1mL of Formic acid in 1Lit of water and the mixture of two components like Buffer and Acetonitrile in the ratio of 40:60 as mobile phase with 1mL/min flow rate at ambient temperature. Analysis was carried out within 10 minutes. The calibration curve was linear in the concentration range from 5.0ng/mL to 100ng/mL (r2 = 0.999) for Ezetimibe and 2.0ng/mL to 40ng/mL (r2 =0.999) for Pitavastatin. All the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rabbit. Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids