In-vitro Comparative Dissolution Study of Different Brands of Ranitidine Hydrochloride Tablets Available in Bangladesh

Abstract

The aim of the study is to find the similarity and difference among the local brands of ranitidine with the innovator brand in Bangladesh. Ranitidine is an antiulcerant drug with H2 antagonist action useful in treating gastric and duodenal disorders. The dissolution test is used to obtain and compare dissolution profiles and establish similarities of pharmaceutical forms. In this study the dissolution profiles of 150-mg coated ranitidine tablets of a reference drug Zantac and a generic Gepin and a similar Xantid drug marketed in Dhaka, Bangladesh using a simple, fast and inexpensive ultraviolet method. Dissolution was determined using a USP type 2 apparatus at 50 rpm with 900 mL of distilled water at 37.0 ± 0.5 ºC for 1h. The dissolution test was performed in compliance with the United States Pharmacopoeia (USP-32). Dissolution efficiency and difference (f1) and similarity (f2) factors were calculated and evaluated. Here the both values of f1 are within the range, below the 15. In this case of f2 though Gepin has the value of 50.78 that means it is in the range of 50-100 and made the brand accepted but in the other hand the Xantid has the value of 47.63 which is below the range so and not accepted. This problem can be due to manufacturing problems or for instrumental limitations.