苯磺酸左旋氨氯地平口崩片质量考察

The Quality Inspection of the L-amlodipine Besylate Orally Disintegrating Tablets

目的:建立苯磺酸左旋氨氯地平口崩片质量控制方法。方法:对制备的口崩片进行有关物质,含量均匀度,崩解时限测定和稳定性考察,含量测定采用kromasil C18柱(250 mm×4.6 mm,5μm),以甲醇-0.03 mol/L的磷酸二氢钾溶液(75:25)为流动相,流速为1 ml/min,检测波长为238 nm。结果:制得的苯磺酸左旋氨氯地平口崩片有关物质均小于1.0%,在0.12～0.87μg范围内的进样量与峰面积有良好的线性关系,含量均匀度符合要求,在30 s内能完全崩解,但在高湿和光照条件下稳定性较差。结论:建立的高效液相色谱测定方法实用可靠,精密度好。

Objective：To establish its quality control method of the L-amlodipine besylate orally disintegrating tablets.Methods：make the determination of the related substance,the content unifirmity,the disintegration and the stability.HPLC was used to measure the content of the L-amlodipine besylate orally disintegrating tablets.A kromasil 250 mm×4.6mm C18 Column was used,with the mobile phase of methanol-KDP of 0.03mol/L（75：25）.The flow rate was 1ml/min,the uv decection wavelength of was set 238nm.Results：the result of the related substance of the orally disintegrating tablets is below 1.0%,The L-amlodipine besylate orally disintegrating tablets show linear relationship with peak areas in the range of 0.12～0.87μg,the tablets can disintegrate in just 30 second and the content unifirmity measure up to the standard.While the stability of the tablets are failed in the condition of light and high humidity.Conclusion：The methods is practical and reliable,besides that it also has good precision.