A comparative Study on Polymorphism of Commercial Ranitidine Hydrochloride Drug Samples in India

Ranitidine hydrochloride is a drug used to treat stomach acid production. It is commonly advised in the treatment of peptic ulcer and gastrophaegal reflux. Ranitidine hydrochloride exists in two different polymorphic forms, namely form I and form II. Various brands of ranitidine hydrochloride tablets manufactured by different pharmaceutical companies in India were collected, finely powdered and recrystallized from ethanol water mixture. The melting points of pure drug samples were determined to assess the polymorphic form present in each sample. All the pure drug samples showed a melting point in the range 135 to 138 °C and prove the existence of polymorph form I. The pure recrystallized drug samples were kept at room temperature for about 60 days in order to study the changes in polymorphic form if any and found fairly stable on prolonged storage. Infrared and UV-visible spectral studies have been carried out by taking Zinetac 150 mg (GlaxoSmithKline Pharmaceuticals Ltd., Mumbai) as the standard in order to prove the chemical constitution of the drug.