高效液相色谱法测定注射用盐酸罂粟碱的含量

Determination of Paparerine Hydrochloride for injection by HPLC

目的建立注射用盐酸罂粟碱中盐酸罂粟碱的含量测定方法。方法采用高效液相色谱法。以甲醇-0.005N庚烷磺酸钠(冰乙酸调pH值至3.0)(55﹕45)为流动相,用外标法按峰面积计算回收率。结果盐酸罂粟碱在1.490～11.920μg/ml范围内,线性关系良好(r=0.9999);平均回收率为99.5,RSD为0.31(n=9)。结论高效液相色谱法操作简便快捷,测定结果准确,可用于注射用盐酸罂粟碱的含量测定和质量控制。

objective HPLC mechool was estahlished for the deter mination of Papaverine hydrochoricde for injection. Method HPLC method was used. The separation was performed on C18 colum with 0.005N 1-heptanesulfonic alid sodium（pH3.0）-methanol（45：55）. Detecton was performed with HPLC 254nm. Result Thecalibration Paparerine Hydrochlorede was linear（1. 490-11. 920μg·ml^-1. r=0. 9999, n=9）. The average recovery of the assay was 99.5%（RSD%=0.31%）. The limit of detection for Papaverine Hydrochloride was 12ng. Conclusion The method had the advantage of simplicity, accuracy and reliability and it may be used for the quantictative Papaverine Hydrochloride for injection.