Abstract

SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF EMPAGLIFLOZIN USING HYDROTROPIC PHENOMENA

Abhishek Bhati*, Jayanti Mukherjee, Vimukta Sharma, Komal Tikariya

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Abstract

Eco friendly Method for the estimation of Empagliflozin using hydrotropic phenomena has been developed and validated. Solubility of EMPA was determined at 25±1°C. Enhancement of solubility was more than 50 and 70% for EMPA respectively in mixed hydrotropic solution. Stability of drugs were observed by dissolving EMPA in Sodium acetate:Urea (2M:8M) solution used as solvent. The maximum absorbance of EMPA was observed at 256.0nm respectively. Response ratio of drug is calculated by dividing the absorbance with respective concentration. The accuracy of the proposed methods was assessed by recovery studies at three different levels i.e. 80%, 100%, 120%. Precision was determined by repeatability (99.715) and Intermediate precision of drug Day to day precision (99.503), Analyst to analyst (99.513) and Reproducibility (99.666). The value of SD and %RSD are less than 2 indicate the precision of method. The assay value of drugs was 99.19 close to 100, SD and % RSD are less than 2 indicate the no interference of excipient in the estimation of drugs.

Keywords: Spectroscopic, Method Development, Validation, Estimation, Empagliflozin, Hydrotrophy.