A simple HPLC method was developed and validated for the simultaneous determination of Paracetamol, Cetirizine HCl and Ambroxol HCl in tablet dosage form by standard addition method. Chromatographic separation of the drugs, achieved on Lichrospher (Merck) C-18 (250 × 4.6 mm, 5 µ) column at 230 nm using mobile phase, comprising a mixture of Methanol:Acetonitrile:Buffer (0.5% w/v Di Potassium hydrogen orthophosphate, pH adjusted to 7 with 1N OPA) in the ratio of 75:3:22 v/v/v, at a flow rate of 1.2 ml/min. Paracetamol, Cetrizine HCl and Ambroxol HCl were eluted at the retention times of 2.5 min, 4.6 min and 7.8 min respectively. Calibration curves were linear over the range of 50-400 μg/ml for paracetamol and 10 µg – 650 μg/ml for both Cetrizine HCl and Ambroxol HCl, r2 values were 0.999, 0.998 and 0.998 respectively. The % assay of Paracetamol, Cetrizine HCl and Ambroxol HCl were found to be 99.8%, 101.6% and 100.1% respectively. The performance of the method was validated according to ICH guidelines. The proposed method was successfully applied for the determination of title drugs in tablet dosage form.
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