Abstract

Nenavath Padmaja¹ and Guttena Veerabhadram²

DOI : http://dx.doi.org/10.13005/ojc/330441

The objective of the present work   was to develop and validate a novel stability indicating RP-UPLC-DAD method for the simultaneous analysis of Metformin and Empagliflozin in bulk and tablet dosage form. This new  RP-UPLC method has  superior in technology to formal  Reverse phase-HPLC with retention time,  solvent utilization, resolution and less cost. The peak area  separation was accomplished on a Waters model UPLC system equipped with PDA detector and  autosampler. A volume of 5 µL of sample and standard were injected into the column and all analytes were separated by using the mobile phase contains mixture  0.1% ortho phosphoric acid buffer  (the pH  was adjusted to 3.4 with 0.1 N NaOH) and methanol  in the ratio 40:60% v/v at a flow rate of 0.25ml/min through C18 BEH(Ethylene Bridged Hybrid)  UPLC (100mm x 2.1mm ,1.8µm) at 35⁰C column temperature and the  detector  wavelength was set at 254 nm. The system suitable parameters such as tailing factor , resolution and plate count of two drugs  were 1.16 , 1.37 ;3.47 ;2314.34 and 4723  respectively. Retention time and peak area and of Metformin and Empagliflozin were found to be 0.882 & 3.471, 4887835 &163463  respectively. Regression equation shows an r value (correlation coefficient) of greater than 0.999 for Metformin and Empagliflozin. Percent recovery of Metformin and Empagliflozin  was found to be 99.92%-100.12% & 100.12%-100.56% respectively .Both Metformin and Empagliflozin were subjected to stress conditions such as acidic, basic, oxidative, thermal and photo degradation butsubstantial degradation was observed in acid studies. The newly developed RP-UPLC-DAD  chromatographicmethod was validated with regard of system suitability, linearity, robustness, accuracy, LOD,precision and LOQ.

Empagliflozin; Metformin; RP-UPLC; Stressstudies; Validation

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