Tuesday , 5 March 2024

Analytical Method Development and Validation for Ezetimibe and Rosuvastatin in API and Combine Pharmaceutical Dosage Forms by RP-HPLC

Dasari Teja1*, Gope Edward Raju2, V. Lakshmi Priya3, Doonaboyina Raghava4, Kavala Nageswara Rao5
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, A.P, India

A b s t r a c t
On the basis of experimental results, the proposed method is suitable for the quantitative determination of Rosuvastatin and Ezetimibe in pharmaceutical dosage form. The method provides great sensitivity, adequate linearity and repeatability. The estimation of Rosuvastatin and Ezetimibe was done by RP-HPLC. The Phosphate buffer was pH 2.5 and the mobile phase was optimized which consists of Acetonitrile: Phosphate buffer mixed in the ratio of 80:20% v/v. A Symmetry C18 (4.6x150mm, 5mm, Make X Terra) column used as stationary phase. The detection was carried out using UV detector at 274 nm. The solutions were chromatographed at a constant flow rate of 0.8ml/min. the linearity range of Rosuvastatin and Ezetimibe were found to be from 25-125mg/ml. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of Rosuvastatin and Ezetimibe LOD and LOQ was found to be within limit. The proposed method is precise, simple and accurate to determine the amount of Rosuvastatin and Ezetimibe in formulation. High percentage of recovery shows that the method is free from the interference of excipients used in the formulation. So the method can be useful in the routine quality control of these drugs.
Keywords: Symmetry C18, Rosuvastatin and Ezetimibe, RP-HPLC.

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