DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF DAPAGLIFLOZIN IN TABLET DOSAGE FORM
Divyang D. Khairnar*, Harshal S. Joshi, Mohit M. Jadiye, Purvesh R. Kalbaile, Rohit K. Patil and Rushikesh S. Patil
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Dapagliflozin in tablet dosage form. Methods: The drug is soluble in 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 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 Dapagliflozin in tablet dosage form and also validated as per ICH guidelines. Results: The drug is soluble in Methanol, slightly soluble in acetonitrile and ethanol and very slightly soluble in water. So, the Methanol is used as a diluent in method. The melting point of Dapagliflozin was found to be 151-152˚C (uncorrected). It showed absorption maxima 240 nm in Methanol. On the basis of absorption spectrum the working concentration was set on 5 μg/ml (PPM). The linearity was observed between 1-9 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 100.9, 101.9 and 98.6% for three levels respectively. The % RSD for precision and ruggedness was found to be 085% and 0.55% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Dapagliflozin in tablet dosage form. The method could be considered for the determination of Dapagliflozin in quality control laboratories.
Keywords: Dapagliflozin, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
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