摘要
目的 建立坎地沙坦酯及其有关物质的HPLC测定方法。方法 采用C18柱,流动相为磷酸缓冲液(磷酸二氢钾2.72 g溶于1 000 mL水中,加磷酸1 mL,混匀后用三乙胺调节pH值为5.8±0.1) -乙腈(48:52);流速为1.0mL·min-1;检测波长为210 nm。结果 坎地沙坦酯浓度在5.0-40.0 μg·mL-1时,方法线性关系良好(r= 0.999 8),回收率为99.8％,坎地沙坦酯最低检测浓度为0.025 ng,可检测到十万分之一的有关物质。结论 该法简便、专属、重现好,可用于测定坎地沙坦酯的含量及对合成过程中的有关物质进行限量控制。
OBJECTIVE To establish an HPLC method for candesartan cilexetil and its related substances. METHODS C18 Column was used. The mobile phase consisted of phosphate buffer (KH2PO1 2. 72 g was added in 1 000 mL water , and then triethylamine was added. pH 5.8±0. 1) -aletonitrile (48 : 52). The detection warelength was 210 nm. The flow rate was 1.0 mL ?mm '. RESULTS The stand and curve of ernodin reference was linear over the range of 5. 0-40. 0 μg·mL-1 , (r = 0. 999 8) with ihe arerage recovery of 99. 8%. CONCLUSIONS The method is simple, convenient, senstitive, and reproducible.
出处
《中南药学》
CAS
2004年第2期80-83,共4页
Central South Pharmacy
