• Miss Jagruti Dolas
• Shailesh Jawarkar
• Miss Rani Jagdish Rode
• Mrs. Gayatri Chinchulkar
• Mohsin Khan

To develop a novel, simple, precise, accurate, reproducible, and validate stability indicating assay method by RP-HPLC for determination of Evogliptin tartrate in the pharmaceutical dosage form. The adequate separation was achieved on Hypersil BDS C18 (250 mm x 4.6 mm 5 µ) column in isocratic mode with a mobile phase consisting of methanol: water: TFA mixture (70: 30: 0.1% v/v) with flow rate 1 ml/min. The detection was carried out at 264 nm. The retention time of Evogliptin tartrate API and tablet was found to be 4.03 min and 4.02 min respectively. The method was validated as per ICH guidelines. Linearity was established for Evogliptin tartrate in the range of 75.25-225.75 µg/ml with an R2 value of 0.999. The mean recovery of Evogliptin tartrate was found to be in the range of 100.58 ± 0.4. The stress degradation studies of Evogliptin tartrate were carried out under acidic, basic, peroxide, thermal and photolytic conditions. Degradation was observed in acid and base stressed sample, but not in peroxide, thermal, and photolytic stressed sample. The proposed method was found to be specific, accurate, precise, and robust can be used for estimation of Evogliptin tartrate in API and pharmaceutical dosage form.

NOVEL METHOD DEVELOPMENT, VALIDATION, AND STABILITY INDICATING ASSAY METHOD FOR EVOGLIPTIN TARTRATE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

"NOVEL METHOD DEVELOPMENT, VALIDATION, AND STABILITY INDICATING ASSAY METHOD FOR EVOGLIPTIN TARTRATE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 2, page no.b327-b345, February-2022, Available :http://www.jetir.org/papers/JETIR2202136.pdf

"NOVEL METHOD DEVELOPMENT, VALIDATION, AND STABILITY INDICATING ASSAY METHOD FOR EVOGLIPTIN TARTRATE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 2, page no. ppb327-b345, February-2022, Available at : http://www.jetir.org/papers/JETIR2202136.pdf