DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF VILDAGLIPTIN IN TABLET DOSAGE FORM
Gayatri A. Gaikwad* and Pranav P. Tambe
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 0.1% NaOH. 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 0.1% NaOH. 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 0.1% NaOH, Soluble in ethanol and DMSO. So, the 0.1% NaOH is used as a diluent in method. The melting point of Vildagliptin was found to be 141-142˚C (uncorrected). It showed absorption maxima 227 nm in 0.1% NaOH. On the basis of absorption spectrum the working concentration was set on 50μg/ml (PPM). The linearity was observed between 10-90 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 98.33% for three levels respectively. The % RSD for precision was found to be 0.33% and for Ruggedness is 0.48%. 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.
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