Abstract
VALIDATED STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT FOR SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND ROSUVASTATIN CALCIUM IN COMBINED TABLET DOSAGE FORM

Priyanka N. Shelke, Padmanabh Deshpande* and Aniket Ithape

ABSTRACT

A new simple, accurate, precise and selective stability-indicating reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous estimation of Amlodepine besylate and Rosuvastatin calcium in combined tablet dosage form. An isocratic, reverse phase HPLC method was developed on Jasco HPLC system equipped with Grace C18 column (150 x 4.6 mm i.d.) using acetonitrile: 50mM sodium acetate (pH adjusted to 3.1 with ortho phosphoric acid) (60: 40, v/v) as mobile phase and detection was carried out at 250 nm. Both the drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results were linear in the range of 10-50 μg mL-1 for both the drugs. The retention times for Amlodepine besylate and Rosuvastatin calcium were 3.6 min and 6.1 min, repectively.

Keywords: RP-HPLC, Amlodipine besylate, Rosuvastatin calcium, Forced degradation.


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