Study on the dissolution behavior of oxytetracycline tablets based on optical and electron microscope analysis
Objective To establish a method for determining the dissolution of oxytetracycline tablets in evaluating differences of in vitro dissolution behavior of products from different enterprises.The root cause of the difference in dissolution behavior was traced by optical microscopy and electron microscopy technology.Methods The dissolution rate was determined by paddle method or high-performance liquid chromatography(HPLC)method.The morphology and dissolution behavior of oxytetracycline and excipients in the tablet core were analyzed by optical and electron microscopy.Results The linear relationship of oxytetracycline was good in the concentration range from 18.5 to 92.6μg/mL,with the average recovery of 98.4％,relative standard deviation(RSD)of 0.7％(n=9),and the method was accurate and reliable.The results of polarizing microscopy and scanning electron microscopy showed that the crystal morphology and existence state of the raw materials and excipients were related to the dissolution behavior of oxytetracycline.Conclusion For polymorphic polycrystalline drugs,the quality of oral solid preparations can be evaluated more effectively and comprehensively by the combination of optical microscopy and electron microscopy analysis.
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