Comparative in vitro equivalence evaluation of Fexofenadine hydrochloride 120 mg generic tablets marketed in Bangladesh

B. S. M. Bodiuzzaman; Sabreena Chowdhury Raka; Arifur Rahman; Nahian Fyrose Fahim; Sherejad Sanam; S. M. Abdur Rahman

Authors

B. S. M. Bodiuzzaman Department of Pharmacy, Faculty of Allied Health Sciences, Daffodil International University, 4/2-Sobhanbagh, Dhanmondi, Dhaka-1207, Bangladesh.
Sabreena Chowdhury Raka Department of Pharmacy, Faculty of Allied Health Sciences, Daffodil International University, 4/2-Sobhanbagh, Dhanmondi, Dhaka-1207, Bangladesh.
Arifur Rahman Department of Pharmacy, BRAC University, 41 Pacific Tower, Mohakhali, Dhaka-1212, Bangladesh.
Nahian Fyrose Fahim Department of Pharmacy, Faculty of Allied Health Sciences, Daffodil International University, 4/2-Sobhanbagh, Dhanmondi, Dhaka-1207, Bangladesh.
Sherejad Sanam Department of Pharmacy, Stamford University Bangladesh, 51 Shiddheswari Rd, Dhaka.
S. M. Abdur Rahman Chemical Biology and DNA Research Lab, Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh.

Keywords:

Substandard; H1-receptor antagonist; Friability; Dissolution; Resistance; Potency

Abstract

The aim of the study is to establish the pharmaceutical equivalence of fexofenadine hydrochloride 120 mg film coated tablets available in Bangladesh. The quality control parameters which are studied are weight variation test, thickness, friability, hardness, disintegration, dissolution and assay specified by BP and USP. The assay value was determined by HPLC. Out of the samples from six evaluated pharmaceutical companies, the potency of fexofenadine hydrochloride tablets from four companies was found to be satisfactory and two was poor of the range. The in-vitro dissolution studies of fexofenadine hydrochloride 120 mg tablets were carried out 0.1N HCl for 10 and 30 minutes using USP-II method. Three samples showed more than 60% drug release within 10 minutes and more than 80% drug release within 30 minutes. Among six samples, five showed hardness within range but one sample did not meet up the hardness level. The % RSD of weight variation of six brands were in the range of ≤ 2. Disintegration time for all brand was within range 30 minutes and complies with the BP/USP recommendation. From the investigation, we can conclude that 70% of the pharmaceutical companies in the urban area produce standard drugs, whereas 30% companies produce substandard drugs.