STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM

Nutan B. Raut, Padmanabh B. Deshpande*, Snehal Dhamodkar and Jay Mehta

ABSTRACT

The present work describes development and validation of a new simple, accurate and precise stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Empagliflozin as bulk drug and in tablet formulation. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out in accordance with ICH guidelines. Empagliflozin was found susceptible to all the analyzed stress conditions. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase and chromatographic separation was achieved by using Chloroform: Methanol: Glacial acetic acid (8.5: 1.5: 0.2, v/v/v) as mobile phase. Densitometric detection was carried out at 225 nm. The retardation factor (Rf) was found to be 0.47±0.03. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The developed method was found to be linear in the concentration range of 200-1200 ng band-1. The LOD and LOQ was found to be 59.62 ng band-1 and 180.68 ng band-1 respectively. The developed method has been successfully applied for the estimation of Empagliflozin in tablet dosage form.

Keywords: Empagliflozin, Stability indicating method, HPTLC, Forced degradation studies.