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Abstract

A VALIDATED RP-HPLC METHOD FOR DETERMINATION OF GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM

Rahul Sahu*, NPS Sengar, Parul D. Mehta and NS Lodhi

A simple, accurate, rapid, precise, specific and cost effective reverse phase high performance liquid chromatography (RP-HPLC) method have been developed and subsequently validated for simultaneous estimation of Guaifenesin (GUA) and Pseudoephedrine hydrochloride (PSE) in pharmaceutical dosage forms. Chromatography is carried out isocratically at 25°C ± 0.5°C on an Prontosil C-18 column (4.6 x 250mm, 5μ particle size) with a mobile phase composed of acetonitrile-methanol-phosphate buffer (pH-5.0) (72:8:20, v/v/v) at a flow rate of 1.2 mL/min. Detection was carried out using a PDA detector at 218 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization guidelines. The retention times for GUA and PSE are 2.99 ± 0.5 min and 5.04 ± 0.5 min respectively. The linearity range for GUA and PSE are 15-75 μgml-1 and 6-30 μgml-1 respectively. The percentage recoveries of GUA and PSE are 98.72 and 98.35% respectively. The correlation coefficients for both components are close to 1. The relative standard deviations for three replicate measurements in three concentrations of samples in tablets are always less than 2%.


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