METHOD DEVELOPMENT AND VALIDATION OF AN ANTI-HYPERTENSIVE AGENT BY USING RP-HPLC
Badikela Ramakrishna*, Kondapuram Parameshwar, Donapati Jalander and Kosika Sandeep
ABSTRACT
A new Simple, rapid and sensitive isocratic RP-HPLC method has been developed and validated for the determination of Atenolol in tablet formulation. The method employs SHIMADZU HPLC system on ODS, C18 column (250*4.6mm and 5 μm). Best chromatographic separation was achieved by using 30mm Ammonium acetate (pH 3): acetonitrile: methanol in the ratio of 50:30:20 as mobile phase with a flow rate of 1.0mL/min and isocratic elution with a total runtime of 5 minutes. Detection of the compound was carried out at 226nm. The retention time of Atenolol was found to be 2.527. The linearity studies ranges from at the concentration range of 60-140μg/ml. This method was validated for accuracy, precision, linearity, ruggedness and robustness as per ICH guidelines. The present newly developed method was found to be accurate, precise and can be useful for routine Quality control analysis.
Keywords: Atenolol, HPLC, ODS, ICH.
[Full Text Article]