苯磺酸氨氯地平片两种含量测定方法比较

Content Determination of Amlodipine Besylate Tablets by HPLC and UV Spectrophotometry

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:DIAMONSIL 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。

OBJECTIVE Content determination of amlodipine besylate in amlodipine besylate tablets by HPLC and UV spectrophotoretric methods. METHODS HPLC method：the chromatographic column of DIAMONSIL C18 （4. 6mm × 250mm ,5 μm） was used. The mobile phase consisted of methanol-0. 03mol · L-1 KH2PO4 （75：25）. the detection wavelength was at 237nm. UV spectrophotoretric method： The UV detection wavelength was set up at 365nm. RESULTS HPLC method：Amlodipine besylate was separated from its related substances thoroughly. The calibrated linear curve of amlodipine was within 15.28 - 33.61 μg·mL -1 （ r = 0. 9994, n = 7 ）. the average recovery rate were 99.79% - 100. 21% with RSD of 0. 33% - 1.11%. UV spectrophotoretrie 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%. CONCLUSION The two methods were simple, rapid, accurate and can be used to eontroll amlodipine besylate and its preparations.