HPLC法测定磷酸咯萘啶注射液的含量

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 C18（150×4．6mm，5μm）；柱温30℃；以乙腈－0．3％三乙胺溶液（磷酸调pH至3．0）（15∶85）为流动相；流速为1．0mL? 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? mL －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。

Detemination of MaIaridine Phosphate in MaIaridine Phosphate Injection by HPLC

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.