Stability Indicating Method for Known and Unknown Impurities Profiling for Vildagliptin in Vildagliptin Tablet

(E-pub Ahead of Print)

Author(s): Nitin Mahajan*, Mazhar Farooqui, Suparna Deshmukh

Journal Name: Current Pharmaceutical Analysis

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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.

Keywords: Impurity profiling, Degradation products, Analytical Method Development, Analytical Method Validation, HPLC, Related substances, Vildagliptin.

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(E-pub Ahead of Print)
DOI: 10.2174/1573412917999201016094821
Price: $95

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