Formulation and analytical method development for simultaneous estimation of domperidone and itopride from sustained release matrix tablet

Sustained Release matrix tablet containing 20mg domperidone and itopride 50 mg were prepared by wet granulation method. Formulation F5 exhibited best drug release, i.e. about 20% drugs were released in 2 hours to give therapeutic effect and sustained the release up to about 12 hours. No drug polymer interaction was observed from IR studies and stability study data shows that the formulation F5 can be stable up to minimum 2 years. UV spectrophotometric scan had been carried out for the determination of maximum wavelength (λmax) of domperidone and itopride. It is revealed that the λmax of itopride and domperidone was at 259 nm and 285 nm respectively and the HPLC parameters for the simultaneous determination of domperidone and itopride was as follows: 10 m.mol Potassium dihydrogen phosphate buffer of pH 6.0: acetonitrile = 60: 40 (v/v) Column: C 18, 250 X 4.6 mm, 5 µm particle size, λmax : 270nm, Flow rate: 1ml/min. where the retention time of itopride and domperidone was found to be 2.077 and 4.167 min, respectively.

Author(s): Sandip G. Badadhe, Sabahuddin S. Siddique and Vikas B. Gawali

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