RP-HPLC法测定HZ08含量及有关物质

Assay of HZ08 and its related substances test by RP-HPLC

目的：建立HZ08（N-腈基-1-[（3，4-二甲氧基苯基）甲基]-3，4-二氢-6，7-二甲氧基-N-辛基-2（1H）-异喹啉碳酰亚胺）的含量测定及有关物质检查方法。方法：采用Lichrospher—C18（250mm×4．6mm，5μm）柱，以甲醇-磷酸盐缓冲液（磷酸二氢钾2．0g，溶于1000mL水，加磷酸2．0mL，用三乙胺调pH至2．6，摇匀，经0．45pm滤膜过滤）（80：20）为流动相，流速为1．0mL·min^-1，检测波长为225nm。结果：HZ08在1．0～200μg·mL^-1。范围响应线性良好（r=0．9999），最低检测限为20ng·mL^-1，与有关物质分离良好。结论：该法可用于HZ08的含量测定及杂质检查，专属准确。

Objective：To establish a RP-HPLC method to quantify a new chemical entity HZ08（ N-cyano-1 - [ （ 3,4-dimethoxyphenyl ） methyl ] -3,4-dihydro-6,7 -dimethoxy-N＇-octyl-2 （ 1H ） -isoquinoline carboximidamide） and its related substances. Methods： The quantification was performed by RP-HPLC consisted of a Lichrospher-C18 column（250 mm ×4.6 mm ,5μm） , an eluate of methanol-phosphate buffer （ pH 2.6, adjusted with triethylamine） （ 80： 20） with a flow rate of 1.0 mL· min^- 1 and a UV detection at 225 nm. Results：The linearity of HZ08 concentration curve was in a range of 1.0 -200μg· mL^-1（ r = 0. 999 9）. The minimal detection limit was 20 ng· mL^-1 The related substances were separated well from HZ08. Conclusions：The selective and reliable RP-HPLC method is usable for the determination of HZ08 and its related substances.