高效液相色谱法测定左卡尼汀片的溶出含量

Determination of levocarnitine tablets's dissolution by HPLC

目的建立高效液相色谱法测定左卡尼汀片的溶出含量。方法采用氨基色谱柱(4.6mm×250mm,5μm);流动相:磷酸二氢钾溶液(6.81g/L,用氢氧化钠调pH值至4.7)∶乙腈(35∶65);流速1.0mL/min;柱温:30℃;检测波长:205nm;进样量:20μL。结果左卡尼汀在浓度0.189～0.756mg/mL的范围内,线性关系良好(r=0.9999),溶出度平均回收率为100.17%,RSD值为0.39%(n=9)。结论本方法简便易行,结果准确可靠,专属性强,适用于左卡尼汀片的溶出含量测定。

Objective To establish an HPLC method for the dissolution determination of the Levocarnitine tablets.Methods Samples were separated on NH2 column（4.6 mm×250 mm,5 μm）using the solution of monopotassium phosphate（6.81 g/L,with sodium hydroxide to adjust pH 4.7）-acetonitrile（35∶65）as the mobile phase at a flow rate of 1 mL/min.The column temperature was 30 ℃.The detective wavelength was 205 nm and the sample size was 20 μL.Results The levocarnitine had good liner relationship in 0.189~0.756 mg/mL（r=0.999 9）,and the average recovery rate was 100.17%,RSD was 0.39%.Conclusion The method is simple,rapid,accurate and precise.