DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF EMPAGLIFLOZIN IN TABLET DOSAGE FORM
Uday L. Bachhav*, Suyog P. Chaudhari, Sunaina S. Manure, Komal S. Joshi, Neha M. Patil5 and Rupali R. Patil
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic
method for estimation of Empagliflozin 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 Empagliflozin in tablet dosage
form and also validated as per ICH guidelines. Results: The drug is soluble in analytical grade methanol, slightly
soluble in ethanol and very slightly soluble in water. So, the analytical grade methanol is used as a diluent in
method. The melting point of Empagliflozin was found to be 151-152˚C (uncorrected). It showed absorption
maxima 276 nm in analytical grade methanol. 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, 99.00 and 99.17% for three levels respectively.
The % RSD for precision was found to be 0.90% and for Ruggedness is 0.56%. Conclusion: A simple, rapid,
linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of
Empagliflozin in tablet dosage form. The method could be considered for the determination of Empagliflozin in
quality control laboratories.
Keywords: Empagliflozin, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
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