HPLC法检测苯磺酸氨氯地平片剂中的乳糖相关杂质

Determination of the Lactose-Related Impurities in Amlodipine Besylate Tablets by HPLC Method

目的:建立HPLC法测定苯磺酸氨氯地平片剂中的乳糖相关杂质含量。方法:分别选择Kromasil 100-5C18柱(250 mm×4.6 mm,5μm)、Xtimate C18柱(250 mm×4.6 mm,5μm)和Agilent HC-C18柱(250 mm×4.6 mm,5μm)为固定相,乙腈-0.05 mol.L-1磷酸二氢钾溶液(以三乙胺调节pH为3.0)(35∶65)为流动相,流速为1.0 mL.min-1,柱温为30℃,检测波长为237 nm。分别以标准曲线法和多浓度点法测定校正因子。结果:2种方法测得的校正因子均为2.2;来自3个厂家的苯磺酸氨氯地平片均未检出乳糖相关杂质。结论:该法可用于测定苯磺酸氨氯地平片剂中的乳糖相关杂质含量。

Objective： To establish a HPLC method for determining the lactose-related impurities in amlodipine besylate tablets. Methods： The analysis was performed on the Kromasil 100-5 Cls column （250 mm ×4.6 mm, 5 μm） ,Xtimate C18 column（250 mm × 4.6 mm, 5 μm） and Agilent HC-C18 column （250 mm× 4. 6 mm, 5 μm）, respectively. The mobile phase was composed of acetonitrile and 0.05 mol.L-1 KHzPO4 aqueous solution （the pH value was adjusted to 3.0 with triethylamine） with the volume ratio of 35 ： 65. The flow rate of mobile phase, column temperature and the detection wavelength were 1.0 mL-min-l, 30 ℃ and 237 nm, respectively. The correction factor was determined and calculated by standard curve method and multi-concentration-points method. Results： The values of correction factor determined by two methods were both 2.2. The lactose-related impurities were not detected in the amlo- dipine besylate tablets coming from three manufacturers. Conclusion： The method can be used for the determination of the lactose-related impurities in amlodipine besylate tablets.