DEVELOPMENT AND VALIDATION OF RP - HPLC METHOD FOR THE ESTIMATION OF VILDAGLIPTIN IN PHARMACEUTICAL DOSAGE FORMS
Praveencumar Ramachandra*, Mahalingam Vasudevan, Deecaraman, Ravandur Shivanna Chandan
ABSTRACT
A simple, accurate, precise and rapid RP - HPLC method was
developed for the determination of Vildagliptin in Pharmaceutical
dosage forms. The chromatographic separation of Vildagliptin was
achieved on a symmetry C18, (150 x 4.6mm, 3.5μ) column using UV
detector at 220 nm. The mobile phase for this optimized isocratic
method consists of Methanol and 10 Mm Ammonium Acetate buffer in
the ratio of 30:70. The flow rate was 1 mL/min. The chromatogram
showed peak of Vildagliptin at retention time of 5.8 min. The method
was validated according to ICH guidelines. The Linearity range was
found to be 50-150 μg/mL. The LOD was found to be 2.3 μg/mL and
LOQ 5.2 μg/mL for the estimation of Vildagliptin. Recovery of
Vildagliptin was found to be between 99.0-99.3%. The proposed
method were found to be linear, precise, accurate, specific and all
proved to be sensitive, convenient and effective for the determination of Vildagliptin in bulk
and pharmaceutical dosage forms.
Keywords: Vildagliptin, RP - HPLC, ICH guidelines.
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