Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

In this article we described the development and validation of stability indicating, accurate, precise and simple ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e., propylparaben and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: buffer: sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar�® Lichrosorb�® C18 column and monitored at wavelength of 230 nm. The averages of the absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and propylparaben, respectively. The limit of quantification and limit of detection were in range of 0.3-2.7 ng mL-1 and 0.1-0.8 ng mL-1, respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed, while all drugs were found almost stable in the other conditions. The developed method was validated in accordance to ICH and AOAC guidelines. The proposed method was successfully applied to quantify the amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.

Biography

Email: najam.edu.pak@gmail.com