Development and Validation of Stability Indicating HPTLC-MS Method for Estimation of Empagliflozin in Pharmaceutical Dosage Form

Abstract

A high-performance thin-layer chromatographic method was developed and validated for estimation of Empagliflozin in pharmaceutical dosage form. The proposed method was applied successfully to the pharmaceutical analysis of the recently approved dosage form of Empagliflozin which is available in market as a brand name of Jardiance tablets. The drugs were satisfactorily show peak with RF 0.65 for Empagliflozin. Method was validated according to the ICH guidelines. The calibration plot was linear between 0.5-5.0 μg per band for Empagliflozin. The LOD and LOQ for Empagliflozin was found to be 0.171 μg per band and 0.521 μg per band, respectively. Accuracy and precision of the proposed method was evaluated by recovery studies (% recovery for Empagliflozin was 99.88%) and intra-day and inter-day precision studies (standard deviation value for precision studies was found to be 0.453. In stability testing, Empagliflozin were found susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. The proposed validated stability indicating assay for the sensitive determination of the mentioned drugs is suitable for Quality control laboratories as a simple fast economic method. Degradation product of Empagliflozin in alkaline condition was carried out and its degradation product is successfully separated and isolated by HPTLC method. degradation product was identified by using MS-MS technique.