Title:Stability Indicating Method for Known and Unknown Impurities Profiling for Vildagliptin in Vildagliptin Tablet
VOLUME: 17
Author(s):Nitin Mahajan*, Mazhar Farooqui and Suparna Deshmukh
Affiliation:Post Graduate and Research Centre, Department of Chemistry, Maulana Azad College of Arts, Science and Commerce, Aurangabad, Maharashtra, Pin code: 431001, Department of Chemistry, Dr. Rafiq Zakaria College for women, Marathwada University, Aurangabad, Maharashtra, Pin code: 431001, Department of Chemistry, S.K Gandhi college, Kada, Tal: Asthi, Dist: Beed, Maharashtra, Pin code: 414202
Keywords: Impurity profiling, Degradation products, Analytical Method Development, Analytical Method Validation, HPLC,
Related substances, Vildagliptin.
Abstract: Background: Vildagliptin is a drug for the treatment of diabetes. DPP-IV inhibitor represents a new class of
oral antihyperglycemic agents to treat patients with type 2 diabetes. Several RP-HPLC method reported for determination
of Vildagliptin alone. However, it was noticed that no stability indicating method is available in any Pharmacopeia
(USP/BP/EP/JP) or in any literature for quantification of known and unknown impurities profiling for Vildagliptin in
Vildagliptin tablets.
Objective: The aim of this study to develop a simple, sensitive, rugged, robust and specific novel gradient stability
indicating RP-HPLC method for quantitative determination of known, unknown impurities and degradants of Vildagliptin
in Vildagliptin Tablets.
Methods: Chromatographic separation has been achieved on Hypersil ODS column (250 x 4.6) mm, 5 μm with mobile
phase consisting mixture of Perchloric acid Buffer, methanol, acetonitrile and Triethyl amine delivered at flow rate of 1.0
mL minute-1 and the detection wavelength 210 nm. The developed method was validated as per ICH guidelines.
Results: Vildagliptin was found degraded significantly under oxidative and alkaline stress condition. The degradation
products were well resolved from Vildagliptin and its impurities. Analytical Method found Linear, accurate and precise
from LOQ (Limit of Quantification) level to 150 % of impurity specification limit (0.5 %).
Conclusion: The method found sensitive, rapid and accurate quantification of known, unknown impurities and
degradants. The peak purity results confirmed that the Vildagliptin peak was homogeneous and pure in all stress samples,
thus proving the stability indicating nature of the method.
