Author(s): Raneem Darraj, Sadik Almekhlafi

Email(s): kkraneeem91@gmail.com

DOI: 10.52711/0974-360X.2025.00045   

Address: Raneem Darraj*, Sadik Almekhlafi
Department of Pharmaceutical Chemistry and Quality Control, College of Pharmacy, Kalamoon University, Syria.
*Corresponding Author

Published In:   Volume - 18,      Issue - 1,     Year - 2025


ABSTRACT:
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


Cite this article:
Raneem Darraj, Sadik Almekhlafi. Assessment of Pharmaceutical Quality Control of three Generic products of Vildagliptin Tablets available in Syrian market. Research Journal of Pharmacy and Technology. 2025;18(1):289-4. doi: 10.52711/0974-360X.2025.00045

Cite(Electronic):
Raneem Darraj, Sadik Almekhlafi. Assessment of Pharmaceutical Quality Control of three Generic products of Vildagliptin Tablets available in Syrian market. Research Journal of Pharmacy and Technology. 2025;18(1):289-4. doi: 10.52711/0974-360X.2025.00045   Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-1-45


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