European Journal of Biomedical and Pharmaceutical Sciences

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN AND VILDAGLIPTIN IN API DOSAGE FORM

*D. Pavan Kumar and M. Satish Kumar

ABSTRACT

Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Remogliflozin and Vildagliptin in pharmaceutical dosage form. Methods: Chromatogram was run through Phenomene x C 18 column (150x4.6mm, 5μm). Mobile phase containing Phosphate buffer, Acetonitril and Methanol in the ratio of 30:05:65 was pumped through column at a flow rate of 1.2 ml/min. Buffer used at pH 4.6. Temperature was maintained at Ambient. Optimized wavelength for Remogliflozin and Vildagliptin was 249 nm. Results: Retention time of Remogliflozin and Vildagliptin were found to be 2.102 min and 3.246 min. The % purity of Remogliflozin and Vildagliptin was found to be 100.348% and 100.049% respectively. The system suitability parameters for Remogliflozin and Vildagliptin such as theoretical plates and tailing factor were found to be 3569.028,4798.716, 1.27 and 1.11. The linearity study for Remogliflozin and Vildagliptin correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 99.03 % and 100.19 %, %RSD for repeatability was 0.944 and 0.548, % RSD for intermediate precision was 0.119 and 0.649 respectively. The precision study was precise, robust and repeatable. LOD value was 0.35 and 0.08, and LOQ value was 1.08 and 0.25 respectively. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Remogliflozin and Vildagliptin in pharmaceutical dosage form.

Keywords: Remogliflozin, Vildagliptin, RP?HPLC, Simultaneous estimation.