多元维生素片中叶酸含量的HPLC测定方法验证

Determination of Folic acid in Centrum tablets by HPLC

目的验证多元维生素片中叶酸含量的高效液相测定方法〔1〕。方法用反相高效液相色谱紫外检测器测定。色谱柱为十八烷基硅烷键合硅胶填充柱,两相流动相按梯度洗脱,流动相A为0.05mol·L-1磷酸二氢钠溶液,流动相B为0.05mol·L-1磷酸二氢钠溶液:乙腈=50∶50(V/V)。流速为1.0mL·min-1。检测波长284nm。结果峰面积与含量有良好的线性(r=0.99999);准确度好,回收率高(=95.0%,RSD=2.05%);精密度高(=1.55)。结论本方法稳定,简便易行,快速准确,线性范围测试,准确度(回收率)测试,专一性测试和精密度测试的结果符合验证方案。

OBJECTIVE Determination of Folic acid in Centrum tablet by RPHPLC.METHODS Determination by RP-HPLC and UV detector.A C18 column was used.Gradient elution was used by Double-phase（phaseA：0.05 mol·L-1 sodium Phosphate Monobasic,phase B：0.05mol·L-1 sodium PhosphateMonoba sic：Acetonitrile=50∶50） Flow rate was 1.0mL·min-1.Wavelength was 284nm.RESULTS The linear regression was good between area and contents（r=0.99999）,The recovery was 95.0%（RSD=2.05%）,The precision was 1.55%.CONCLUSION The method is simple,rapid and accurate.The test results of linearity,accuracy,specificity and precision meet the specifications from test method validation protocol.