Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Empagliflozin and Metformin Hydrochloride in Bulk Drug and Tablet Dosage Form.

Abstract

Background

Type 2 diabetes mellitus is a chronic condition that affects millions of people worldwide. The combination of Empagliflozin and Metformin hydrochloride in tablet form is commonly used for the treatment of this condition. Accurate and precise determination of these drugs in their combined dosage form is crucial for quality control and effective therapeutic outcomes.

Objective

To develop and validate a selective, accurate, and precise reverse phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Empagliflozin and Metformin hydrochloride in combined tablet dosage form.

Method

Chromatographic separation was achieved using a Cosmosil C18 column (250mm x 4.6ID, Particle size: 5 micron) with a mobile phase consisting of Methanol:KH₂PO₄ Buffer (60:40). The retention times (RT) for Empagliflozin and Metformin hydrochloride were 6.7 and 4.1 minutes, respectively. The flow rate was set at 0.8 ml/min, and detection was performed at an ultraviolet wavelength of 227 nm. The method was validated according to ICH guidelines.

Result

The linearity ranges for Empagliflozin and Metformin hydrochloride were 1-5 µg/mL and 40-200 µg/mL, respectively, with regression coefficients (R²) of 0.9966 and 0.9971. Precision studies indicated that the % R.S.D. was less than 2%. The % assay of Empagliflozin and Metformin hydrochloride were 99.94% and 99.80%, respectively.

Conclusion

The developed RP-HPLC method is selective, accurate, and precise for the simultaneous determination of Empagliflozin and Metformin hydrochloride in combined tablet dosage form. This validated method complies with ICH guidelines and is suitable for routine quality control analysis in pharmaceutical settings.