Abstract

A NOVEL UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kavana D. C.* and Naveen Kumar G. S.

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Abstract

The quantification of Dapagliflozin in pharmaceutical dosage forms and bulk drug has been accomplished through the development and validation of a new, precise, and effective zero-order derivative UV spectroscopic method. In acetonitrile and ethanol (70:30), Dapagliflozin shows its maximum absorbance at 224 nm, and its concentration ranges between 3 and 18 μg/mL according to Beer's Law. A correlation coefficient (R2) of 0.998 demonstrated the method's strong linearity, indicating high consistency and reliability throughout the range under study. The recovery rates ranged from 99.51% to 101.35%, while the limits of detection (LOD) and quantification (LOQ) were found to be 0.0985 μg/mL and 0.298 μg/mL, respectively. Relative standard deviation (%RSD) values were less than 2%, indicating that the method was also very precise. The ICH guidelines were followed in evaluating the following validation parameters: linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ. This verified spectroscopic method is a reliable and repeatable way to routinely analyse Dapagliflozin in different pharmaceutical preparations.

Keywords: Dapagliflozin, Zero order derivative spectroscopy, Validation, Pharmaceutical formulation.