Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN BY USING QUALITY BY DESIGN APPROACH

Amruta S. Khurd*, Pankaj B. Miniyar, Sandip R. More, Kajal V. Doshi, Vandana Gawande, Abhijeet S. Sutar, Arun M. Kashid, Shraddha V. Tathe, Shubhangee S. Gaikwad

ABSTRACT

The objective of this study was to develop a new rapid and robust high-performance thin layer chromatographic (HPTLC) method for estimation of Vildagliptin in tablet dosage form using quality by design approach. Chromatography was performed using pre-coated silica gel aluminium plate 60 F254, (10 ×10 cm) as stationary phase and Isopropyl alcohol:Methanol:Ammonia Solution (6:4:0.2, v/v/v) as mobile phase. Detection was carried out at 222 nm. The linear regression analysis data for the calibration plots showed r2 > 0.99 with a concentration range from 50-300 ng/band. A Box–Behnken experimental design with randomized response surface methodology was applied. Band length, saturation time, development distance was set as independent variables while CAAs identified were peak area and retardation factor. The Rf value was predicted for vildagliptin 0.50±0.05 to optimize the chromatographic conditions based on the preliminary trials. The optimized HPTLC method was validated according to International Conference on Harmonization guideline (ICH Q2 R1). The studies successfully demonstrate the use of QbD approach for developing the highly sensitive HPTLC method with enhanced method performance. Developed HPTLC method was successfully applied for routine analysis of Vildagliptin in bulk and tablet dosage form.

Keywords: Vildagliptin, HPTLC, Validation, CAAs, Box -Behnken design.


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