DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF VILDAGLIPTIN IN TABLET DOSAGE FORM
*Mrudula Sonawane, Madhavi Deore, Dipak Chinchore, Aditya Darade, Bhushan Mahajan, Mande Prajwal and Uday Bachhav
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Vildagliptin in tablet dosage form. Methods: The drug is freely soluble in Water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in Water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Vildagliptin in tablet dosage form and also validated as per ICH guidelines. Results: The drug is freely soluble in Water and Ethanol, Practically insoluble in ethyl acetate and insoluble in acetone. So, the Water is used as a diluent in method. The melting point of Vildagliptin was found to be 149-150˚C (uncorrected). It showed absorption maxima 230 nm in Water. On the basis of absorption spectrum the working concentration was set on 30 μg/ml (PPM). The linearity was observed between 10-50 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.0, 99.0 and 98.2% for three levels respectively. The % RSD for precision and ruggedness was found to be 1.08% and 0.31% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Vildagliptin in tablet dosage form. The method could be considered for the determination of Vildagliptin in quality control laboratories.
Keywords: Vildagliptin, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
