HPLC测定马来酸依那普利叶酸片中两种组分的含量

Simultaneous Determination of Two Components in Enalapril Maleate Folic Acid Tablets by HPLC

目的 建立同时测定马来酸依那普利叶酸片中马来酸依那普利和叶酸含量的方法。方法 采用离子对反相高效液相色谱法。C18柱，以乙腈-40mmol·L^-1磷酸氢二钾溶液（40：60）（含10mmol·L^-1的十六烷基三甲基溴化铵，用磷酸调pH到7．5）为流动相。流速为1．0mL·min^-1，检测波长为215nm，柱温为60℃。结果 马来酸、叶酸和依那普利之间能够达到很好分离；马来酸依那普利的线性范围为202．5～810．0mg·L^-1，r=0．9998（n=6），平均回收率为99．91％，RSD=1．15％（n=9）；叶酸的线性范围为16．28～65．12mg·L^-1，r=0．9998（n=6），平均回收率为100．11％，RSD=1．20％（n=9）。结论 该法能够同时测定两组分的含量，而且简便、准确、快速，可用于批次样品的含量测定及质量控制。

OBJECTIVE To develop a method for the determination of enalapfil maleate and folic acid in enalapril maleate folic acid tablets. METHODS The separation was performed on a C18 column. The mobile phase was a mixture of acetonirile-40 mmol·L^-1 dipotassium hydrogen phosphate solution（40： 60, containing 10 mmol·L^-1 cetrimonium bromide, adjust pH to 7.5 by phosphoric acid） and the flow rate was 1.0 mL·min^- 1, with the detection wavelength at 215 nm. The column temperature was at 60℃. RESULTS The resolution of maleic acid, folic acid and enalapril was good. The linear calibration curves were obtained over the range of 202.5 - 810.0 mg·L^-1 for enalapfil maleate（ r = 0.999 8, n = 6） and 16.28～65.12 mg·L^-1 for folic acid（ r = 0.999 8, n = 6）, respectively. The mean recoveries of the two compounds were 99.91% and 100.11% with RSD of 1.15% and 1.20%, respectively. CONCLUSION This method is simple, rapid, accurate and suitable for the quality control of samples.