DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR EVOGLIPTIN AND METFORMIN IN BULK AND TABLETS Authors: Shelke S ,TALE A, THAKARE B*, MOHITE B, KALWE R AND WAGHMODE P
ABSTRACT
A combination of Metformin and Evogliptin is used to treat type 2 diabetes mellitus. A selective,
accurate and precise RPHPLC method was developed and validated for simultaneous estimation
of these drugs in bulk and tablet dosage forms. The drugs were resolved on a C18 (150mm ×
4.6mm, 5?) column using Acetonitrile: water (75:25 v/v) as the mobile phase. The detection
wavelength was 226 nm. The retention times obtained for metformin and evogliptin were 1.187&
2.273 min respectively. The linearity ranges were 250-1250 & 2.5-12.5 ?g/ml respectively with
Regression coefficients of 0.9974 & 0.9994. The % RSD of precision studies was found to be less
than 2%. The Accuracy of the proposed method was determined by recovery studies and the mean
recovery was found to be in between 98-102%. The method was also applicable for quantitative
analyses of the marketed tablet formulations and in studying stability of the drugs under acidic,
alkaline, oxidation, thermal and UV conditions.
Keywords: RP-HPLC; Method Development; Validation; Metformin; Evogliptin Publication date: 01/04/2025 https://ijbpas.com/pdf/2025/April/MS_IJBPAS_2025_8857.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2025/14.4.8857