COMPARATIVE IN-VITRO QUALITY EVALUATION OF ERYTHROMYCIN STEARATE TABLETS MARKETED IN ADDIS ABABA, ETHIOPIAAbstract
In this study, an attempt was made to assess the physicochemical equivalence of four brands of Erythromycin stearate tablets marketed in Addis Ababa. Identity, weight uniformity, disintegration, dissolution and assay for the content of active ingredients were evaluated using the methods described in the British Pharmacopoeia 2007. All the samples passed the identity, disintegration, and dissolution tests but Erythromycin stearate (Produced in Sudan by General Medicines Company) failed to release 80% of the drug content within 45 minutes. It also failed to fulfill the tolerance limits for assay stipulated in the pharmacopoeia. This product therefore does not comply with the BP 2007 dissolution and Assay tolerance limits. This work revealed that the four products included in the study complied with the physicochemical quality parameters except Erythromycin stearate which failed to meet the pharmacopoeial specification for dissolution test and assay.
Gebremariam Birhanu, Frehiwot Kassa, Ariaya Hymete and Ayenew Ashenef*
Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia
18 September, 2012
06 December, 2012
22 December, 2012
01 January, 2013