Abstract
Present work describes the development and validation of a simple and reliable high-performance
liquid chromatography-diode array detection (HPLC-DAD) procedure for the analysis
of phenylephrine hydrochloride (PHE), paracetamol (PAR) and cetirizine dihydrochloride
(CET), in pharmaceutical mixture. The method was applied successfully on tablet dosage
form. Effective chromatographic separation of PHE, PAR and CET was achieved using
a Kinetex-C18 (4.6, 150 mm, 5 mm) column with gradient elution of the mobile phase
composed of 10 mM phosphate buffer (pH 3.3) and acetonitrile. The elution was a 3
step gradient elution program step-1 started initially with 2% (by volume) acetonitrile
and 98% phosphate buffer (pH 3.3) for first 2 min. In step-2 acetonitrile concentration
changed linearly to 20% upto 12 min the analysis was concluded by step-3 changing
acetonitrile to 2% upto 20 min. The reliability and analytical performance of the
proposed HPLC procedure were statistically validated with respect to linearity, ranges,
precision, accuracy, selectivity and robustness. Calibration curves were linear in
the ranges 5–15, 250–750 and 2.5–7.5 μg/ml for PHE, PAR and CET, with correlation
coefficients >0.9996. The validated HPLC method was applied to a pharmaceutical mixture
of a marketed preparation tablet in which the analytes were successfully quantified
with good recovery values with no interfering peaks from the excipents.
Key words
phenylephrine - paracetamol - cetirizine - HPLC-DAD
