Development and Validation of an RP-HPLC Method for Determination of Empagliflozin in Empagliflozin Tablet


Authors : Dr. K M Khairul Alam; Tanbin Jahan Ferdousy

Volume/Issue : Volume 8 - 2023, Issue 5 - May

Google Scholar : https://bit.ly/3TmGbDi

Scribd : https://tinyurl.com/35r7xw99

DOI : https://doi.org/10.5281/zenodo.8113095

Abstract :  Background: Reversed-phase HPLC (RP-HPLC) is a prevalent chromatographic technique in the pharmaceutical field. At present, there is no pharmacopoeial method to estimate Empagliflozin in Empagliflozin tablets, although a number of Empagliflozin brands in tablet forms are sold in local pharmacies. In this study, an RPHPLC method has been developed and validated for estimation of Empagliflozin in Empagliflozin 10mg tablets. The correlation coefficient was found 0.999 that indicated the linearity of the proposed method. Specificity and robustness of the method were also confirmed. Conclusion: The RP-HPLC method for estimation of Empagliflozin in Empagliflozin tablet has been developed and validated as per the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines with regard to the validation parameters.

Keywords : Empagliflozin, RP-HPLC, Method Development, Validation, Tablet.

 Background: Reversed-phase HPLC (RP-HPLC) is a prevalent chromatographic technique in the pharmaceutical field. At present, there is no pharmacopoeial method to estimate Empagliflozin in Empagliflozin tablets, although a number of Empagliflozin brands in tablet forms are sold in local pharmacies. In this study, an RPHPLC method has been developed and validated for estimation of Empagliflozin in Empagliflozin 10mg tablets. The correlation coefficient was found 0.999 that indicated the linearity of the proposed method. Specificity and robustness of the method were also confirmed. Conclusion: The RP-HPLC method for estimation of Empagliflozin in Empagliflozin tablet has been developed and validated as per the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines with regard to the validation parameters.

Keywords : Empagliflozin, RP-HPLC, Method Development, Validation, Tablet.

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