DEVELOPMENT AND VALIDATION OF UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND SIMVASTATIN FROM ITS PHARMACEUTICAL DOSAGE FORM
Keywords:
UPLC, Sitagliptin, Simvastatin, Validation, Method development.Abstract
A modified simple, selective, rapid, precise reversed phase ultra performance liquid chromatography method has been developed and validated for the simultaneous estimation of sitagliptin and simvastatin. The method was carried out on Waters Acquity BEH C18, 50×2.1 mm, 1.7 μm UPLC column with a mobile phase consisting of water : acetonitrile (30:70) adjusted to pH 4.0 with orthophosphoric acid. The flow rate was 0.35 ml/min and the effluent was monitored at 236 nm . The validation of the proposed method was also carried out in terms of linearity, accuracy, precision, symmetry factor, plate count, regression, and recovery. In conclusion this method can be used for routine quality control analysis due to its simplicity and accuracy.
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