叶酸口腔速溶膜剂的质量控制

Quality control of fast dissolving oral films of folic acid

目的:建立叶酸口腔速溶膜剂的质量控制方法。方法:利用HPLC法测定叶酸口腔速溶膜剂的含量及膜剂的含量均匀度。色谱条件:Innoval ODS-2 C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相:甲醇-0.054 mol/L磷酸二氢钾溶液(调节p H=6.3±0.1)(8:92);检测波长:λ=254 nm;流速1.0 mL/min;进样量为20μL;柱温为(30±1)℃。结果:叶酸在40.0~260.0μg/L的浓度范围内线性关系良好(R=0.999 8),平均加样回收率为99.02%,RSD为0.41%。结论:该色谱测定条件及含量测定方法能够简单有效地测定叶酸口腔速溶膜剂的含量及含量均匀度。

Objective：To establish an appropriate method to determine contents of fast-dissolving oral films of folic acid.Methods：Content and content uniformity of fast-dissolving oral films of folic acid were determined by an HPLC method,in which a Innoval ODS-2 C18 column（250 mm×4.6 mm,5μm）was used as stationary phase and a mix of methanol-0.054 mol/L KH2PO4（adjusted to p H 6.3±0.1 with0.5%NH3·H2O）was used as mobile phase.The detection wavelength was 254 nm and the flow rate was 1.0 mL/min.Column temperature was set at 30℃.Results：The concentration detection of folic acid showed a fine linearity between 40.0-120.0μg/L（R=0.999 8）,the average recoveries of folic acid was 99.02%,and corresponding RSD value was 0.41%.Conclusion：The detection method in this study is simple and accurate,so it could be used in the quality control of the fast-dissolving oral films of folic acid.