Development and validation of a novel isocratic RP-HPLC method for simultaneous determination of atenolol and aspirin in fixed dose combinations

Abstract

In this study, reverse phase high performance liquid chromatographic method have been developed and validated for the simultaneous determination of Atenolol and Aspirin in combined pharmaceutical formulation. HPLC separation was achieved with a Phenomenex - Luna, C18 (250 x 4.6 mm i.d., 5μ) as stationary phase and phosphate buffer (pH adjusted to 4.5 with ortho phosphoric acid): Methanol (85:15 v/v) as eluent, at a flow rate of 0.8 ml/min. UV detection was performed at 239.5 nm. The retention time of Atenolol and Aspirin was found to be 5.1 and 12.5 min respectively. Results of the analysis were validated statistically and by recovery studies. Linearity, accuracy, and precision were acceptable in the ranges (20-100 μg/ml) for Aspirin and (10-50 μg/ml) for Atenolol. The calibration curves were linear (r2 > 0.999) in the range for each analyte. The % recovery for Atenolol and Aspirin is 99.17 and 99.75 respectively. No spectral or chromatographic interferences from the tablet excipients were found. The result of the studies showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which can be used for the routine determination of Atenolol and Aspirin in bulk and in its pharmaceutical dosage forms.