昂丹司琼口腔溶解薄膜剂含量测定方法的研究

Study of Test Method for Assay of Ondansetron in Ondansetron Oral Soluble Film

目的建立昂丹司琼口腔溶解薄膜剂含量测定方法。方法采用HPLC法测定昂丹司琼口腔溶解薄膜剂中昂丹司琼的含量。结果 HPLC法测定的平均回收率为99.9%,RSD为0.3%,回收率良好。昂丹司琼在5.1∽1022.4μg/mL浓度范围内浓度与峰面积呈良好的线性关系,r=1.0。结论采用HPLC法测定昂丹司琼口腔溶解薄膜中昂丹司琼的含量,专属性强,灵敏度高,重现性好,能够很好的控制产品的质量,将该法订入质量标准。

Objective Set up Test method for assay of Ondansetron in Ondansetron oral soluble film.Method Test assay of Ondansetron in Ondansetron oral soluble film by HPLC method.Result Accuracy is satisfactory with average recovery is 99.9% and RSD is 0.3%. Linearity is satisfactory in the range of 5.1 μg/mL to 1022.4 μg/mL, The correlation coefficient（r） is 1.0.Conclusion The HPLC method for assay of Ondansetron in Ondansetron oral soluble film is specificity and sensitivity. The method can control quality of product well. It will be used in the product specification.