In this article we describe development and validation of stability indicating, accurate, specific, 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 230nm. The averages of 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 to 2.7 ng mL-1 and 0.1 to 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 with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.
Abstract:-A simple, isocraticRP HPLC-UV method was developed for the simultaneous determination of chlorhexidine (CHD) and p-Chloroaniline (pCA) inchlorhexidine mouth rinses. An excellent separation obtainedbyC18 column (200mm × 4.6 mm, 3μm). Mobile phasewas acetate buffer:methanol in a 45:55 ratio,flowrate was 1.0 ml/min. Both ingredient and an impuritywere detected at 254 nm,injection volume was 20µl and the analysis temperature was room temperature.Resolution4.7,retention times was3.1min and 5.7 min for pCAand CHD respectively. The proposed method was testedforsystem suitability, linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. The linearity range was40-160µg/ml forCHD and0.3-1.2 µg/ml forpCA.The correlation coefficient of the regression line was 1.000 for both components. Method robustness was tested under nine different conditions using sampleswith a known content. For CHD, the mean of the nine assays was 99.95% andthe RSD was 0.16%. ForpCA, the mean of the nine assays was 99.98% and the RSD was 0.24%. The results show that this is a simple method that can be applied to the analysis of Chlorhexidineproductswith satisfactory degrees of accuracy and precision. Due to the selected optimized conditions, this method can be used with the minimum requirements of an isocratic HPLC system.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.