Assessment of pharmaceutical quality control of three generic products of vildagliptin tablets available in Syrian market

Vildagliptin is a dipeptidyl peptidase-4 inhibitor used to treat diabetes mellitus. Quality control of pharmaceutical products is an essential operation because it affects on the human health. Evaluation if Vildagliptin local Syrian brand comparing with the reference drug Galvus® (Novartis Pharma). Many physical and chemical quality control tests were applied to Vildagliptin tablets including weight variation, friability, hardness tests in addition to disintegration, dissolution and drug content using modified constitutional chromatography method. The results of physical and chemical tests showed that the tablets within acceptable limits, which allows the use of the tablets of local companies safely. The tests of weight variation, friability, hardness testes were between 182.51±7 to 234.78mg, 0.03 to 0.27% and 7.02±0.43kg/cm² to 8.49±0.57kg/cm² respectively. All tablet disintegrated within 2.02 min to 7.06 min in distilled water. The drug release (%) in 0.01 HCL and phosphate-buffered saline (PBS) (pH 6.8) after 40 min were between 95.52% to 98.57%. Result assay using HPLC showed that drug content (%) range between 93.29% to 97.24%. The result validation of the analytical method was verified, as the value of the coefficient of determination R was equal to 0.997, which indicates the linearity of this method within the range of concentrations (60-120)%, limit of detection (LOD) is 1.135μg\ml.