DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND ASPIRIN IN MARKETED FORMULATION

Abstract

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Rosuvastatin calcium and Aspirin from Capsule dosage forms using C18 column (Grace Smart (250mm x 4.6mm, 5 $\mu $m). The sample was analyzed using Water (0.5 ml tri-ethyl amine in 100mL of double distilled water): Acetonitrile in the ratio of 50:50(% v/v) pH adjusted to 4.0 with orthophosphoric acid, as a mobile phase at a flow rate of 1.0 mL/min and detection at 243 nm. The retention time for Rosuvastatin calcium and Aspirin was found to be 4.30 and 3.44 min respectively. The method can be used for estimation of combination of these drugs in capsules. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 6 – 14 $\mu $g/mL (r²=0.9997) for Rosuvastatin calcium and 45 – 105 $\mu $g/mL (r²=0.9989) for Aspirin and assay of capsules were between 98.0-102.0%. Due to these attributes, the proposed method could be used for routine quality control analysis of these drugs in combined dosage forms.