Development and Validation of a Simple RP-HPLC Method for Simultaneous Estimation of Remogliflozin and Vildagliptin in Bulk and Pharmaceutical Dosage Forms.

AbstractA simple, precise, accurate, and rapid reverse-phase high-performance liquid chromatographic(RP-HPLC) method was developed and validated for the simultaneous estimation ofRemogliflozin and Vildagliptin in bulk drugs and pharmaceutical dosage forms.Chromatographic separation was achieved on a C18 column using an optimized mobile phase ofacetonitrile and phosphate buffer (75:25, v/v) at a flow rate of 0.8 mL/min with UV detection at215 nm. The retention times of Remogliflozin and Vildagliptin were found to be 3.05 min and6.48 min, respectively. The method exhibited excellent linearity over concentration ranges of66–396 μg/mL for Remogliflozin and 10–60 μg/mL for Vildagliptin with correlation coefficientsof 0.998 and 0.999, respectively. The developed method was validated according to ICHguidelines and demonstrated satisfactory accuracy, precision, robustness, and sensitivity.Recovery values ranged from 99.46% to 100.81% for Remogliflozin and 99.59% to 100.46% forVildagliptin. Precision studies showed %RSD values below 2%, indicating good reproducibility.The limits of detection and quantification were found to be 2.80 and 8.485 μg/mL forRemogliflozin and 0.55 and 1.674 μg/mL for Vildagliptin, respectively. The method wassuccessfully applied to the assay of marketed tablet formulations, yielding assay values withinacceptable limits. The validated RP-HPLC method was found to be suitable for routine qualitycontrol analysis of Remogliflozin and Vildagliptin in combined pharmaceutical dosage forms.