Open AccessHPLC Method Development for the Estimation of Empagliflozin in Bulk and Pharmaceutical Formulation
Author(s) -
Asmita V. Gaikwad,
Preeti Khulbe
Publication year - 2022
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2022/v34i23b35926
Subject(s) - empagliflozin , chromatography , detection limit , high performance liquid chromatography , linear range , pharmaceutical formulation , chemistry , materials science , analytical chemistry (journal) , medicine , endocrinology , diabetes mellitus , type 2 diabetes mellitus
An efficient and simple HPLC method has been developed and validated for the determination of Empagliflozin in marketed formulations. The mobile phase used for the chromatographic runs consisted of Water:ACN (55:45 v/v). The separation was achieved on a Symmetry, Waters C-18, 100 x 4.6 mm, 2.7 um, Poroshell 120 EC-C18, using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 225 nm. The method was linear at the concentration range of 2–12 μg/ml for both the formulations. The method has been validated according to ICH guidelines concerning precision, accuracy, and forced degradation. Empagliflozin limit of detection (LOD) and limit of quantification (LOQ) were 0.005938 ng/ml and 0.017813 ng/ml respectively.