Wed, 22 Nov 2017

Development and Validation of RP-LC Method For Simultaneous Estimation of Rosuvastatin And Ezetimibe In Bulk and Its Pharmaceutical Formulations

Anil Shahaji Khile1, N. Gayatri Devi2, M. Subba Rao2 and D. Ramachandran2*

1. Department of Chemistry, Rayalaseema University, Kurnool, Andhra Pradesh.

2. Department of Chemistry, Acharya Nagarjuna University, Nagarjuna nagar, Guntur. Andhra Pradesh, India.


ABSTRACT

A new simple, accurate, rapid and precise isocratic RP-HPLC was developed and validated for the determination of Rosuvastatin and Ezetimibe in Pharmaceutical tablet dosage form by droping method. The Method employs Shimadzu LC system on Hypersil ODS column (4.6 x 250 mm, 5 µm) and flow rate of 1.5ml/min with an injection volume 20µl.  Buffer, Acetonitrile and Methanol was used as mobile phase in the composition of 40:30:30v/v. The Detection was carried out at 230nm. Linearity ranges for Rosuvastatin and Ezetimibe were 11-33µg/ml, 10-30µg/ml respectively for HPLC. Retention Time of Rosuvastatin and Ezetimibe were found to be 3.7 and 5.7 min respectively. Percent Recovery study values of Rosuvastatin and Ezetimibe were found 99.6-101.1% and 99.9-100.7% respectively. This newly developed method i.e. droping method was successfully utilized for the Quantitative estimation of Rosuvastatin and Ezetimibe in tablet dosage form. This method was validated for selectivity, accuracy, precision, and linearity, Ruggedness, Robustness and Stability Studies as per ICH guidelines.

Keywords: Liquid Chromatography; Rosuvastatin, Ezetimibe, Simultaneous estimation, Validation.


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