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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMVASTATIN AND EZETAMIB IN BULK DOSAGE FORM BY UPLC METHOD

Mannem.Anithakumari*, Dhanalakshmi.K.Nagarjuna Reddy.G

ABSTRACT

Objective: A new, simple, rapid, sensitive, precise, accurate and effective UPLC method has been developed and validated for the analysis of Simvastatin and Ezetamib in bulk and tablet dosage formulation as per United States of pharmacopeia (USP) guidelines. In UPLC, the Chromatographic separation was achieved on Aquity UPLC BEHphenyl 1.7μm *2.1mm,100mm and the detection wave length at 230 nm using a mobile phase of 1g orthophosphoric acid,100% methanol, pH was adjusted to 3 with 0.1N NaoH. In UPLC, the retention time for Simvastatin was found to be 4.755 ± 0.21 min. Linearity was observed in the concentration range of 25-150mcg with a correlation coefficient 0.9998. The % RSD value for precision was found to be 1.41 and the mean recovery was found to be 99.99. And EZETAMIB was found to be 3.183min. The amount of drug estimated was found to be in good agreement with label claim. The method was validated and found to be simple, sensitive, accurate and precise as per USP guidelines by UPLC.

Keywords: USP, UPLC, Simvastatin.


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