Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF EZETIMIBE AND SIMVASTATIN IN BULK AND COMBINED TABLET DOSAGE FORM.

Sonali M. Patil*, S. R. Bavaskar and S. D. Barhate

Abstract

A new Simple, Precise, Fast and Accurate RP-HPLC Method has been developed and validated for simultaneous estimation of Ezetimibe and Simvastatin in bulk and combined dosage form. The method was carried out on the chromatographic separation was achieved by isocratic elution technique on (reverse phase) Primesil C18 column (250 mm x 4.6 mm ID, Particle size 5μm), using mobile phase composition of Methanol: Water (0.05%OPA) in the ratio of 90:10 v/v with a flow rate 1.0ml/min. The separation was observed at 239 nm. The retention time of Ezetimibe and Simvastatin were found to be 3.98 min and 7.91 min respectively. The Ezetimibe and Simvastatin followed linearity in the concentration range of 5-25μg/ml and 5- 25μg/ml respectively with r²=0.999 for both Ezetimibe and Simvastatin. The amount of both drugs estimated by the proposed method was found to be in good agreement with labelled claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in combined dosage form.

Keywords: Ezetimibe and Simvastatin, RP-HPLC, Validation.