DEVELOPMENT AND VALIDATION OF A METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN A FORMULATION BY RP-UPLC
S. Madhavi* and A. Prameela Rani
ABSTRACT
In the present study, a rapid, an accurate and precise Ultra Performance
Liquid Chromatography (UPLC) method was developed and validated
for simultaneous estimation of Saxagliptin and Dapagliflozin in its
tablet dosage form (10mg Dapagliflozin and 5mg Saxagliptin) by
selecting chromatographic parameters. The UPLC method was
developed using 2.1 × 100 mm, reverse phase C18 column (Acquity
UPLC ethylene bridge hybrid (BEH) C18 1.7 μm) with mobile phases
containing 0.1% ortho phosphoric acid and acetonitrile (40:60) as
mobile phase. Flow rate was 0.3 ml/min with PDA detection at (λmax)
254 nm and the injection volume was set at 1 μl with run time 3 min.
The method was validated by using various validation parameters like
accuracy, precision, linearity and robustness. These results show the
method could find practical application as a quality control tool for analysis of the drug in its
tablet dosage forms in pharmaceutical industries.
Keywords: Saxagliptin, Dapagliflozin, UPLC, Validation, method.
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