OBJECTIVE Content determination of amlodipine besylate in amlod ipine besylate tablets by HPLC and UV spectrophotoretric methods.METHOD S HPLC method:the chromatographic column of DIAMONSIL C18(4.6mm×250m m,5μm) was used.The mobile phase consisted of methanol-0.03mol·L-1 K H2PO4 (75∶25).the detection wavelength was at 237nm.UV spectro photoretric method:The UV detection wavelength was set up at 365nm.RESULTSWTBZ HPLC method:Amlodipine besylate was separated from its related substances t horoughly.The calibrated linear curve of amlodipine was within 15.28~33.61μg·mL-1(r=0.9994,n=7).the average recovery rate were 99.79%~100.21% with RSD of 0.33%~1.11%.UV spectrophotoretric method:the standard curve was linear in the range of 5.1~45.9μg·mL-1(r=0.9997,n=9).The average recovery rate were 96.65%~98.13% with the RSD of 0.55%~1.32%.CONC LUSION The two methods were simple,rapid,accurate and can be used to controll amlodipine besylate and its preparations.%目的 采用高效液相色谱法和紫外分光光度法同时测定苯磺酸氨氯地平片的含量,为质量控制提供有效的分析手段.方法 高效液相色谱法:色谱柱:DI AMONSIL C18(4.6mm×250mm,5μm);流动相:甲醇-0.03mol·L-1磷酸二氢钾水溶液(75∶25);检测波长:237nm.紫外分光光度法:检测波长:365nm.结果 高效液相色谱法:制剂中其它成分不干扰测定,氨氯地平峰和杂质峰达到有效分离.氨氯地平浓度在15.28~33.61μg·mL-1范围内线性关系良好(r=0.9994,n=7),平均回收率为99.79%~100.21%,RSD为0.33%~1.11%.紫外分光光度法:氨氯地平浓度在5.1~45.9μg·mL-1浓度范围内具有良好的线性关系(r=0.9997,n=9),平均回收率为96.65%~98.13%,RSD为0.55%~1.32%.结论 两种方法均可用作苯磺酸氨氯地平片剂的质量控制.
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