Comparative In Vitro Equivalence Evaluation of Some Loratadine Generic Tablets Marketed in Bangladesh
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2017, Vol 12, Issue 2
Abstract
Loratadine is a potent, rapidly effective and long-acting non-sedative, histamine H1 receptor antagonist, with anti-allergic properties. The purpose of this research work was to evaluate the pharmaceutical equivalent of six different brands of loratadine 10 mg tablets using various pharmacopoeial and nonpharmacopoeial tests with special landmark on in vitro dissolution study and with different price ranges purchased from retail pharmacies of Bangladesh. All brands complied with the official specification for friability, uniformity of weight and disintegration time but four brands did not comply with the official specification for hardness. Assay of loratadine tablets revealed that all samples contained 86.65-95.02% of labeled potency. Drug release was satisfactory for all brands, since more than 96.76% of the loratadine was dissolved in the medium within an hour of the test. The dissolution profiles were compared with the use of model independent approaches of difference factor and similarity factor, showing that all brands are similar with brand L3 and can be used interchangeably.
Authors and Affiliations
Tasnim Motaher Oishi, Sanjida Munna, Zainab Noor,, Sajan Das, Rumana Akhter, Sumaiya Huque, Mohammad Shahriar*
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