New Method for Determination of Omeprazole Enteric-coated Pellets Relative Sphericity

OBJECTIVE To develope a new method for the determination of pellets relative sphericity by using commercially available omeprazole enteric-coated pellets as model drug.METHODS The initial morphological analysis of the samples was carried out by image analysis method.Then the relative sphericity was quantitatively measured and analyzed by the circular surface rolling method combined with the characteristics of pellets.RESULTS The relative sphericity of multi-batch samples A was >80%,and there was no significant difference in the relative sphericity in batches.The pellet samples produced by each manufacturer had great differences in appearance morphology,the relative sphericity were (82.74±1.48)%,(88.03±3.40)%,(88.20±3.42)% and (65.63±5.91)% for sample A,B,C and D,indicating that the domestic manufacturers in the prescription composition,preparation process or key process parameters control conditions were likely to exist some differences.CONCLUSION The established method is simple,good for large samples and accurate.