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Development & Validation of RP-HPLC Method for the Determination of Oseltamivir Phosphate in Bulk Drug & in Dosage

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Author(s): S M Malipatil | Kishwar Jahan | S K Patil

Journal: Indo Global Journal of Pharmaceutical Sciences
ISSN 2249-1023

Volume: 1;
Issue: 1;
Start page: 57;
Date: 2011;
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Keywords: Oseltamivir phosphate (OSP) | RP-HPLC

ABSTRACT
The present study describes the development of a new, simple, reproducible RP-HPLC method for the quantitative determination of Oseltamivir phosphate (OSP). The proposed method utilizes purosphere column 250mm x 4.6mm x 5.0μm at 30 ◦C with isocratic run using Ammonium acetate buffer 6.9 PH and Acetonitrile (60:40 v/v) at a flow rate of 1ml/min. and UV detection at 220 nm. The method was statistically validated for linearity, ruggedness, robustness,precision, and accuracy. The calibration curve was obtained in the concentration range of 1.5-12μg/ml with correlation coefficient 0.999. The robustness of the method has been studied by slightly varying the chromatographic conditions. The ruggedness of the method was determined by carrying out the experiments on two different instruments like Shimadzu-Prominence and Agillent-1100. It was observed that there were no marked changes in the chromatograms, this shows the developed method is rugged and robust. The precision of the method was determined by inter-day and intraday variation studies having RSD values less than 1% showing high precision of the method. The tailing factor was found to be 1.34. Due to its simplicity, accuracy, high precision the proposed method may be used to determine Oseltamivir phosphate in bulk drug as well in the pharmaceutical formulations. © 2011 IGJPS. All rights reserved
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