Evaluation of the pharmaceutical quality of different brands of ranitidine tablets manufactured in Bangladesh: A pharmaceutical and public health prospective

• Main Authors: Akter, R. (Author), Howlader, A.N.M.A.-N (Author), Ismail, N.E (Author), Karim, M.F.B (Author), Ming, L.C (Author), Raju, A.A (Author), Rana, M. (Author), Rashid, M.S (Author), Sarker, M.M.R (Author)
• Format: Article
• Language: English
• Published: Open Science Publishers LLP Inc. 2016
• Subjects: Bangladesh; Disintegration time; Quality of drugs; Ranitidine; Spectrophotometric analysis; Spurious drugs; Substandard and Counterfeit drugs
• Online Access: View Fulltext in Publisher
• ISBN: 22313354 (ISSN)
• ISSN: 22313354 (ISSN)
• DOI: 10.7324/JAPS.2016.60109

Drug counterfeiting and production of substandard drug is a global problem. Substandard or counterfeit drugs are threat for the effective treatment of diseases and highly worsen the quality of life of patients. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health. © 2016 Md. Moklesur Rahman Sarker et al.