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Development and Validation of RP-HPLC Method for Estimation of Empagliflozin and its Stability Studies In vitro Simulated Gastric and Intestinal Fluids Patil Sushil D*, Bharambe Swapnapurti V*, Kshirsagar Sanjay Pharmaceutical Quality Assurance Technique, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgoan, Nashik. Savitribai Phule Pune University *Corresponding Author E-mail: sushilpharma@rediffmail.com
Online published on 31 December, 2019. Abstract A simple and precise high performance liquid chromatography method for determination of Empagliflozin and its stability studies invitro simulated gastric and intestinal fluids. The separation was carried out on Cosmosil C18 (250mm X 4.6, 5μ) RP-HPLC column using a 0.8ml/min as flow rate with methanol: water (80: 20 v/v) mobile phase and RT was 5.017min. Quantification was performed with a UV detector at 224nm, solubility and stability was determined individually in simulated biological fluids at various pH was investigated. The calibration curves of EMPA were linear in the range of 10–50 μg/ml(R²=0.999). The developed method was applied to pharmaceutical formulation successfully with no interfering peaks. The percentage recovery was 99.71–100.29%. It was observed that solubility of EMPA was increased in all in vitro interaction medium, freely soluble in pH 6.8 and slightly in 1.2 and 7.4 pH and the stability of EMPA was stable or less degraded in pH 6.8 for 24 hours. Top Keywords Empagliflozin, gastric fluid simulant, intestinal fluid simulant. Top | |
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