Stability indicating assay method for estimation of Empagliflozin using HPTLC

Vineeta Khanvilkar*, Gayatri Vinchurkar, Deepali Kadwadkar, Darshana Pardeshi, Pratik Jadhav

Department of Quality Assurance, Faculty of Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, Maharashtra, India

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Vineeta Khanvilkar, Gayatri Vinchurkar, Deepali Kadwadkar, Darshana Pardeshi, Pratik Jadhav. 2025. Stability indicating assay method for estimation of Empagliflozin using HPTLC. Journal of medical pharmaceutical and allied sciences, V 14 - I 1, Pages - 7017 – 7023. Doi: https://doi.org/10.55522/jmpas.V14I1.6782.

ABSTRACT

A planer chromatographic method capable of indicating the stability of the empagliflozin was developed and validated. Separations were achieved on the silica gel 60F254 as the planar stationary phase and a solvent mixture comprising of Chloroform, Toluene, Methyl alcohol, and Methanolic acid mixed in a proportion of 8:4:2:0.1 v/v/v/v. Examination of the band developed for empagliflozin indicated a densito metric value with an retardation factor of 0.33±0.02. The calibration data analysis through linear regression showed a statistically significant correlation (R2 > 0.990) between peak area and concentration covering concentrations from 100 to 700 ng applied to the spot. The method was validated to check if it was accurate, precise, linear, and robust following the International Council for Harmonization guidelines. Detection and quantitation limit of the method also were determined. Empagliflozin was further subjected to forced degradation followed by analysis using the proposed method on the samples. The analytical method enabled precise, selective, and accurate analysis of Empagliflozin when its degradation products were present. The method developed can be used to quantitatively analyze Empagliflozin in bulk drug, formulations, and stability studies.

Keywords:

Empagliflozin, Validation, Degradation, Robustness, linearity.

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