DEVELOPMENT AND VALIDATION METHOD FOR THE SIMULTANEOUS ESTIMATION OF EMPAGLIFLOZIN LINAGLIPTIN, AND METFORMIN IN SOLID DOSAGE FORMS BY OF RP-HPLC

The purpose of the investigation was to develop a simple, rapid and accurate RP-HPLC method to determine assay of Linagliptin, Empagliflozin and Metformin in solid dosage forms. Simultaneous Estimation of Linagliptin, Empagliflozin and Metformin were carried out by RP- HPLC using trimethylamine buffer & acetonitrile and Agilent Eclipse XDB (250 mmx 4.6mm, 5µ) as a stationary phase and peak was observed at 240 nm which was selected as a wavelength for quantitative estimation. After the development of the method, it was validated for various parameters. It was found that recovery value of pure drug was between 99 % to 101% which indicates that the method is accurate and also reveals that commonly used excipients and additives present in the pharmaceutical formulations were not interfering in the proposed methods. The ruggedness of the method was checked by different analysts and found that the results were nearly same which indicates that the method is rugged. Based on the results observed, it was concluded that proposed method can be used for routine analysis of Linagliptin, Empagliflozin and Metformin. Keywords: RP-HPLC, Linagliptin, Empagliflozin and Metformin.