Physicochemical properties of loratadine tablets in Sudan, Amro A. H. Mohamed
Amro Abdallah Hasanen Mohamed, University of Medical Sciences and Technology, Sudan
COMPARATIVE STUDY OF PHYSICOCHEMICAL PROPERTIES OF LORATADINE TABLETS (10 MG) IN RETAIL OUTLETS IN KHARTOUM CITY, SUDAN
Purpose: The aim of this study is to evaluate the impact of the poor monitoring system of Sudanese regulatory authorities on the quality of antihistamine tablet (Loratdine).
Methodology: This study includes three different brands of Loratadine tablets from a local private pharmacy, two of which are locally manufactured in Sudan and the third is manufactured in India. The tablets were evaluated against weight variation, friability, hardness, drug content, identification, disintegration time, diameter uniformity and along with In-Vitro dissolution test and then results were compared with international standards.
Findings: By the end of all tests, in the all three brands, friability is found to be less than 1%, hardness is within 4–12 kg, weight variation (there is no tablet deviates by more than twice that percentage), diameter uniformity (<5%), disintegration time (less than 15 min), identification (retention times of both standard and samples are 4 min), content percentage (90 to 110%) and dissolution was not less than 80%.
Originality/value: On the basis of the data submitted during the repeat use procedure, all brands demonstrated satisfactory results. Thus, no negative impact of the poor implemented systems can be considered in this paper.
Keywords: Quality; Sudan; Loratadine; Evaluate; Private pharmacy; HPLC; Poor implemented systems; Dissolution; Identification
Reference to this paper should be made as follows: Mohamed, A.A.H. (2015) ‘Comparative Study of Physicochemical Properties of Loratadine Tablets (10 mg) in Retail Outlets in Khartoum City, Sudan’, Int. J. Food, Nutrition and Public Health, Vol. 7, No. 2, pp.101–110.