High Performance Thin Layer Chromatography (HPTLC) Method Development and Validation for Determination of Empagliflozin

Abstract

Background: Empagliflozin is an antidiabetic drug used in the management of type 2 diabetes. Reliable and cost-effective analytical methods are required for its quality control in pharmaceutical formulations. This study focuses on developing and validating an HPTLC method for its accurate determination. Aims: An SGLT2 inhibitor reduces glucose levels by increasing its excretion through the kidneys in the form of urine. Besides reducing the chances of death due to heart problems, it treats conditions such as chronic kidney disorders, heart failure, and type 2 diabetes mellitus. The estimation of pharmaceutical formulations of the recent formulation of empagliflozin that has been approved and marketed can be achieved through an HPTLC procedure that has been developed and validated. Methodology: Precoated silica gel 60 F254 TLC plates were used in chromatography using toluene as a solvent system. The mobile phase is methanol:ethyl acetate (6:2:2 v/v/v). Detection was performed at 254 nm. Results: Guidelines from the ICH were considered in validating the technique. For empagliflozin, the calibration curve was linear in the range 100-600 ng/band. The LOD and LOQ of empagliflozin were found to be 10.11 ng/band and 30.56 ng/band, respectively. Accuracy and precision of the proposed method were evaluated through recovery studies (the % recovery of empagliflozin was 99.88%), and intra-day and inter-day precision studies (the standard deviation values of precision studies were determined as 0.23-0.85 and 0.21-0.71, respectively). Conclusion: This method is well-validated according to ICH guidelines, and from the statistical analysis we conclude that it is accurate, precise, sensitive, specific, and reproducible. Commercial form and bulk powder of empagliflozin can be analyzed routinely for quality control purposes.