BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EMPAGLIFLOZIN IN HUMAN PLASMA BY CHROMATOGRAPHIC METHOD: A REVIEW Authors: Jambhulkar Y* And Gokhale N
ABSTRACT
Bioanalysis is the method used to determine the concentration of drugs, their metabolites in the
biological matrices such as blood plasma, serum, cerebrospinal fluid, urine and saliva. Bioanalytical
method employed for the quantitative determination of drugs and their metabolites in biological fluids
plays a significant role in the evaluation and interpretation of bioequivalence, pharmacokinetics and
toxic kinetic studies. For various types of drug approval processes at different timings to regulate and
harmonize bioanalytical method development and validation is required. Gas chromatography, highpressure liquid chromatography, LC and GC, combined with mass spectrometric (MS) procedures
such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS are used for quantitative analysis. Techniques
such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double
mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body.
Empagliflozin(EMPA) is an orally active, potent and selective inhibitor of sodium glucose cotransporter 2 (SGLT2), currently in clinical development to improve glycaemic control in adults with
type 2 diabetes mellitus (T2DM). SGLT2 inhibitors, including empagliflozin, are the first
pharmacological class of antidiabetes agents to target the kidney in order to remove excess glucose
from the body and, thus, offer new options for T2DM management. SGLT2 inhibitors exert their
effects independently of insulin. This review covers most recent bioanalytical methods such as
various chromatographic methods and other methods for determination of Empagliflozin in various
pharmaceutical dosage forms were reported.
Keywords: Antidiabetic drug, Empagliflozin (EMPA), Bioanalytical methods
Publication date: 01/05/2022 https://ijbpas.com/pdf/2022/May/MS_IJBPAS_2022_6071.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.5.6071