VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM

Authors

  • Swathi Sri D Institute of Pharmaceutical Technology
  • Hemant Kumar T VIGNAN INSTITUTE OF PHARMACEUTICAL TECHNOLOGY
  • Vara Prasada Rao K Institute of Pharmaceutical Technology
  • Srinivasa Rao Y Institute of Pharmaceutical Technology

Keywords:

Rosuvastatin Calcium, Ezetimibe, Method development, Validation

Abstract

Objective: To develop and validate a rapid, sensitive and specific reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous determination of Rosuvastatin Calcium and Ezetimibe in a combined dosage form.

Methods: The chromatographic separation of the two drugs were achieved using Enable C18G (5 μm, 250 mm x 4.6 mm i. d. column). The drugs were separated in isocratic elution mode with a mobile phase consists of Acetonitrile-Water (75:25, v/v) at a flow rate of 0.6 ml/min and a detection wavelength of 252 nm using a UV detector.

Results: The linearity and range for both Rosuvastatin Calcium and Ezetimibe were 5-40 µg/ml (R2= 0.9995) and 5-40 µg/ml (R2= 0.9992), respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the preanalyzed test solution and was found to be 99.6-100.3 % and 99.5-99.9% for Rosuvastatin Calcium and Ezetimibe respectively. The % RSD values for both interday and intraday precision were found to be<2%.

Conclusion: A rapid, sensitive and specific RP-HPLC method was developed and validated for simultaneous determination of Rosuvastatin Calcium and Ezetimibe in a combined dosage form and hence, it can be used in the quality control analysis of an active pharmaceutical ingredient and pharmaceutical dosage form.

 

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Author Biography

Hemant Kumar T, VIGNAN INSTITUTE OF PHARMACEUTICAL TECHNOLOGY

ASSISTANT PROFESSOR  

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Published

01-04-2015

How to Cite

D, S. S., H. K. T, V. P. Rao K, and S. R. Y. “VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 4, Apr. 2015, pp. 209-13, https://innovareacademics.in/journals/index.php/ijpps/article/view/3989.

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