development and validation RP-HPLC method for Estimation of Rosuvastatin and Ezetimibe in pharmaceutical dosage form.
Ranjit Sul, Miss. Vanita Gade
Rosuvastatin, Ezetimibe, RP-HPLC, Robustness, %RSD, Precision, LOD, LOQ, Accuracy, linear.
A precise and robust method was developed method for the estimation of Rosuvastatin and Ezetimibe in bulk and pharmaceutical dosage form. The Method used Agilent 1260 Infinity II model HPLC with DAD detector and Agilent Poroshell EC-120 C18 column (150 mm × 4.6 mm, 4 m). The Mobile phase combination used was 0. .1% Trifluoroacetic acid, Methanol and Acetonitrile [30:40:30]. Flow rate at 1 ml/min and wavelength at 232 nm with run time of 6 minutes. The retention time of Rosuvastatin (RSV) and Ezetimibe (EZB) peaks was at 2.34 and 2.99 minutes, respectively. The developed method was validated according to ICH Q2 (R1) guidelines. The instrument precision for RSV & EZB had a %RSD of 0.16% and 0.12%, respectively. The Intra & Inter day precision for RSV & EZB had a %RSD of 0.50% and 0.55%, respectively. Method was linear and accurate for concentration range of 80-120 g/ml and 40-60 g/ml for RSV & EZB respectively, with regression coefficient of 0.999 for both RSV & EZB and % RSD for accuracy for RSV at 80%, 100% and 120% was found to be 0.18%, 0.16% and 0.07%, respectively; and for EZB at 80%, 100% and 120% was found to be 0.18%, 0.08% and 0.12% respectively. The LOD & LOQ for RSV are 0.35 g/ml and 1.06 g/ml respectively and the LOD & LOQ for EZB are 0.10 g/ml and 0.29 g/ml respectively.
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Unique Paper ID: 166055

Publication Volume & Issue: Volume 11, Issue 2

Page(s): 461 - 471
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