DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF SAXAGLIPTIN IN TABLET DOSAGE FORM
Uday L. Bachhav*, Vishwesh V. Upasani, Sunaina S. Manure, Komal P. Heda, Bhagyashri S. Nerpagar and Umar Farooque Shaikh Shabbeer
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Saxagliptin in tablet dosage form. Methods: The drug is freely soluble in analytical grade methanol. 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 analytical grade methanol. 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 Saxagliptin in tablet dosage form and also validated as per ICH guidelines. Results: The drug is freely soluble in analytical grade methanol, Sparingly soluble in water and slightly soluble in ethyl acetate. So, the analytical grade methanol is used as a diluent in method. The melting point of Saxagliptin was found to be 108-109˚C (uncorrected). It showed absorption maxima 213 nm in analytical grade methanol. On the basis of absorption spectrum the working concentration was set on 50 µg/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, 99.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.88% and for Ruggedness is 1.16%. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Saxagliptin in tablet dosage form. The method could be considered for the determination of Saxagliptin in quality control laboratories.
Keywords: Saxagliptin, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
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