HPLC法测定盐酸哌唑嗪消旋山莨菪碱片中盐酸哌唑嗪及消旋山莨菪碱的含量

Determination of Content of Raceanisodamine and Prazosin Hydrochloride in Prazosin Hydrochloride Raceanisodamine Tablets by HPLC

目的建立盐酸哌唑嗪消旋山莨菪碱片中消旋山莨菪碱、盐酸哌唑嗪的含量测定方法。方法 HPLC法Fortis C18分析柱（250 mm×4.6 mm,5μm）,甲醇-（3.484 g·L-1戊烷磺酸钠溶液与3.64 g·L-1四甲基氢氧化铵溶液用醋酸调节p H值为5.0）（45∶55）为流动相,流速：1.0 ml·min-1,检测波长225 nm。结果消旋山莨菪碱回归方程为Y=3639 X-172.87,r=0.9998（n=6）,消旋山莨菪碱浓度在5.625~225μg·ml-1范围内呈线性关系,平均回收率为99.86%,RSD为0.95%。盐酸哌唑嗪回归方程为Y=27 637 X＋8100.8,r=0.9999（n=6）,盐酸哌唑嗪浓度在1.9925~79.7μg·ml-1范围内呈线性关系,平均回收率为100.41%,RSD为1.15%。结论本方法简便、准确、快速、可以作为该制剂的含量测定方法。

Objective To establish a method of determining the content of raceanisodamine and prazosin hydrochloride in prazosin hydrochloride raceanisodamine tablets.Methods HPLC Fortis C18 analytical column（250 mm × 4.6 mm,5 μm） was used and the mobile phase was methanol-a mixture solution of 3.484 g·L-1sodium pentanesulfonate solution and 3.64 g·L-1tetramethyl ammonium hydroxide solution with p H adjusted to 5 by acetic acid（45∶ 55）.The flow rate was 1.0 ml·min-1and the detection wavelength was 225 nm.Results For raceanisodamine,the regression equation was Y = 3639 X-172.87,r = 0.9998（n = 6）,the linearity ranged from 5.625 to 225 μg·ml-1,the average recovery was 99.86% and RSD was 0.95%.For prazosin hydrochloride,the regression equation was Y = 27 637 X ＋ 8100.8,r = 0.9999（n = 6）,the linearity was between 1.9925 and 79.7 μg·ml-1,the average recovery was 100.41% and RSD was 1.15%.Conclusion This HPLC method is accurate,quick and simple for determining the content of the compound.