Development and validation of HPLC method for simultaneous quantification of prifinium bromide paracetamol combination in pharmaceutical formulations

Abstract EN

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.