Development and Validation of Hplc Method for Simultaneous Quantification of Prifinium Bromide / Paracetamol Combination in Pharmaceutical Formulations

Abstract

A simple, rapid, accurate and precise HPLC method was developed and validated for the simultaneous quantification of prifinium bromide and paracetamol combination in pharmaceutical dosage form. The separation was achieved on a normal phase-nitrile (CN) column. The mobile phase consisted of 30 mM ammonium acetate buffer–acetonirtile (50%:50%, v/v) at pH = 6.5. The UV detection was carried out at a wavelength of 254 nm. A linear response was observed over a concentration range 3–50 μg/mL for prifinium bromide and paracetamol. The limit of detection for prifinium bromide was 0.75 μg/mL and its limit of quantification was 2.30 μg/mL. For paracetamol, the limit of detection was 0.64 μg/mL while its limit of quantification was 1.60 μg/mL. The method was validated for linearity, accuracy, precision and robustness. The validated method was applied to the analysis of prifinium bromide and paracetamol in commercial Riabal ® Compound tablets.