Development and Validation of a Reversed-Phase HPLC Method For Simultaneous Determination of Aspirin, Atenolol and Amlodipine in Capsules Dosage Forms

A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Aspirin, Amlodipine and Atenolol in capsules. The chromatographic separation was carried out on an Cosmosil packed C18-MS-II(4.6 I.D.x250mm; 5μ particle size) with a mixture of acetonitrile: ammonium acetate buffer pH 4.6 adjusted with 30%v/v acetic acid (80:20, v/v) as mobile phase; at a flow rate of 0.8 ml/min. UV detection was performed at 233 nm. The retention times were 4.415, 3.688 and 3.001 min. for Aspirin, Amlodipine and Atenolol, respectively. Calibration plots were linear (r2>0.998) over the concentration range 1–6 μg/ml for Amlodipine, 5–30 μg/ml for Aspirin and 2.5–15 μg/ml Atenolol. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of capsules. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Aspirin, Amlodipine and Atenolol in bulk drug and capsule dosage form.