Sunday , 15 May 2022

Analytical Method Development and Validation for the Simultaneous Estimation of Metformin and Vildagliptin by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Punna Venkateshwarlu*, CH. Shankar
Department of Pharmaceutical Analysis, Vikas College of Pharmaceutical Sciences, Rayanigudem, Suryapet, Nalgonda, Telangana, India-508376

The chromatographic conditions were successfully developed for the separation of Metformin and Vildagliptin by using C18 Column (150 mm x 4.6 mm) 5 µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer PH 3.0 (70:30 v/v), detection wavelength was 271 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, UV detector, Empower-software version 2. The retention times were found to be 1.692 min and 3.344 min. The % purity of Metformin and Vildagliptin was found to be 99.24% and 100.27% respectively. The system suitability parameters for Metformin and Vildagliptin such as theoretical plates and tailing factor were found to be 2993, 1.23 and 5735, 1.12. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Metformin and Vildagliptin was found in the concentration range of 50 ppm-250 ppm and 5ppm -50 ppm and correlation coefficient (r2) was found to be 0.999 and 0.999 respectively, % recovery was found to be 99.56% and 99.47% respectively. %RSD for repeatability and precision was found to be <2. LOD values were 2.17 and 0.0372 and LOQ value were 6.60 and 0.112 respectively for Metformin and Vildagliptin.

Keywords: Metformin, Vildagliptin, HPLC.

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