孟鲁司特钠咀嚼片含量测定及初步稳定性研究

Assay of montelukast sodium chewable tablets and preliminary stability

目的为实现对孟鲁司特钠咀嚼片质量的关键指标的控制和制剂稳定性研究。方法建立一种专属性好,灵敏度高,快速,准确的HPLC分析方法,测定3批次孟鲁司特钠咀嚼片中孟鲁司特钠含量;并通过高温、高湿度、强光照射试验和加速试验及长期稳定性试验,进行制剂的初步稳定性试验。结果建立的方法经验证,孟鲁司特钠的线性范围为0.5～16.0μg/mL,检测限为0.12μg/mL,定量限为0.39μg/mL,平均加样回收率分别是99.7%、101.2%和99.8%,精密度试验RSD值为1.04%、1.23%和1.27%,初步稳定性试验中含量变化的RSD值均为1.22%、1.67%和1.45%。结论该方法分析时间短、专属性好、准确度高,可用于孟鲁司特钠咀嚼片中孟鲁司特钠含量测定。孟鲁司特钠咀嚼片质量稳定,符合要求。

Objective To achieve quality control of montelukast sodium chewable tablets for the key factors and the stability studies of preparation. Methods A good specificity,high sensitivity,fast and accurate HPLC method has been established and applied to the determination of montelukast sodium assay in three batches of montelukast sodium chewable tablets and the preliminary stability test of the preparation has been explored through the high temperature,high humidity,bright light test and accelerated test as well as long-term stability test. Results The established method has been validated,and the linear range of sufentanil is 0.5～16.0μg/mL,the limit of determination is 0.12μg/mL and the limit of quantification is 0.391.L g/mL,the average recoveries are 99.7%,101.2 % and 99.8%,RSD values of the precision is 1.04%,1.23% and 1.27%. RSD values of the preliminary stability test is 1.22%,1.67% and 1.45%. Conclusion The analysis time of the method is short and the method has high specificity,accuracy,can be used for assay of montelukast sodium chewable tablets. The quality of montelukast sodium chewable tablets is stable and meets the requirements.