HPLC法测定磷酸咯萘啶注射液的含量

Detemination of Malaridine Phosphate in Malaridine Phosphate Injection by HPLC

目的建立HPLC法测定磷酸咯萘啶注射液的方法。方法色谱柱为Kromasil C_(18)(150×4.6mm,5μm);柱温30℃;以乙腈-0.3%三乙胺溶液(磷酸调p H至3.0)(15∶85)为流动相;流速为1.0m L·min^(-1);检测波长为277nm。采用外标法测定磷酸咯萘啶的含量。结果磷酸咯萘啶在20.0~160.0μg·m L^(-1)范围内,线性关系良好(r=1.0000,n=5),平均回收率为:100.3%,RSD=0.2%。结论本方法操作简单,结果准确可靠,可以有效地用于控制磷酸咯萘啶注射液的药品质量。

OBJECTIVE To establish a method for the simultaneous determination of malaridine phosphate in Malaridine Phosphate injection by HPLC .METHODS The chromatographic separation was performed on a Kroma-sil C18 column （100×4.6mm,5μm）,the column temperature was maintained at 30℃.Acetonitrile-0.3%of three tri-ethylamine acetonitrile solution （adjusted to pH 3 with phosphoric acid）（15∶85） as the mobile phase,the flow rate of 1.0 mL· min^-1 .The UV detection wavelength was 277 nm.RESULTS The linear range was within 20-160μg· mL^-1 for malaridine phosphate .The recovery rate was 100.3%with RSD of 0.2%.CONCLUSION This meth-od is simple ,accurate and reliable ,which can be effectively used to control the drug quality of Malaridine Phosphate injection.