Abstract

SIMULTANEOUS ESTIMATION OF EMPAGLIFLOZIN AND LINAGLIPTIN BY RP-HPLC METHOD

Anjali Bakshi*, A. Mounika, Shweta Bhutada and Dr. M. Bhagvan Raju

ABSTRACT

The RP-HPLC method was developed for simultaneous determination of Empagliflozin and Linagliptin in combinations as the pharmaceutical dosage form. Chromatographic separation was achieved on a THERMO® C18 (250mmx4.6mm, 5μm) column applying an isocratic elution based on potassium dihydrogen phosphate buffer pH (3.4) - methanol (70:30, v/v) as a mobile phase. Linearity, accuracy, and precision were found to be acceptable over the concentration ranges of 50-150 μg/ml for Empagliflozin and Linagliptin, respectively. All the variables were studied to optimize the chromatographic conditions. The optimized method was validated and proved to be suitable for the quality control of the mentioned drugs in their different pharmaceutical dosage forms, according to ICH guidelines. The developed method was found to be fairly precise, rapid and economical for simultaneous estimation of Empagliflozin and Linagliptin when compared with the reported method.

Keywords: Linagliptin, Empagliflozin, High-performance liquid chromatography, validation.