• Dr.D.D.Gaikwad
• Mr.S.G.Patel
• Ms.A.J.Hulawale

Aim: This study was conducted in order to compare the bioavailability of two extended-release tablets containing 5 mg of cetirizine dihydrochloride and 120 mg of pseudoephedrine hydrochloride. Methods: Fourty subjects were enrolled in a single-center, randomized, single-dose, open-label, two-way crossover study with a one-week washout period. Plasma samples were collected up 32 hours following drug administration and both analytes were determined by liquid chromatography-tandem mass spectrometry (LCMS/ MS) method with turboionspray mode. Pharmacokinetic parameters used for bioequivalence assessment were AUC0-t, AUC0-∞ and Cmax. Results: The 90% confidence intervals obtained by analysis of variance for AUC0-t, AUC0-∞ and Cmax were 93.79-106.89%, 93.26-106.37%, 94.14-112.44% for cetirizine and 87.19-108.31%, 87.91-109.51%, 96.34-112.64% for pseudoephedrine, respectively. Both formulations were tolerated and no serious adverse events were reported. These results were all within the range of 80.00-125.00%. Conclusion: Bioequivalence between formulations was concluded both in terms of rate and extent of absorption.

Bioequivalence; cetirizine; pharmacokinetic; pseudoephedrine

"BIOEQUIVALENCE STUDY OF CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLET IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.7, Issue 6, page no.1594-1606, June 2020, Available :http://www.jetir.org/papers/JETIR2006565.pdf

"BIOEQUIVALENCE STUDY OF CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLET IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.7, Issue 6, page no. pp1594-1606, June 2020, Available at : http://www.jetir.org/papers/JETIR2006565.pdf