Estimation of four drugs: Ambroxol hydrochloride, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Paracetamol by RP-HPLC in tablet dosage form

Abstract

A simple, specific, precise, accurate and economic isocratic RP-HPLC method was developed for the simultaneous determination of Ambroxol hydrochloride, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Paracetamol in bulk and tablet dosage form. A reverse phase Nucleosil C18 column (250 mm x 4.6 mm x 5 µm) with mobile phase consisting of Methanol: Sodium Phosphate dibasic anhydrous Buffer (65:35 V/V) having (pH of buffer 7.0 ± 0.02 adjusted with ortho phosphoric acid) was used. The flow rate was 1.0 mL/min and the effluents were monitored at 230 nm. The retention times of Paracetamol, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Ambroxol hydrochloride were found to be 3.117, 4.925, 6.217 and 12.308 min. respectively. The method was validated in terms of linearity, range, specificity, accuracy, precision and robustness. The proposed method was successfully applied for the estimation of paracetamol, levocetirizine hydrochloride, phenylephrine hydrochloride and ambroxol hydrochloride in combined tablet dosage form.