高效液相色谱法测定重酒石酸卡巴拉汀胶囊含量

目的: 建立测定重酒石酸卡巴拉汀胶囊含量的高效液相色谱法。 方法: 选用5C₁₈-MS-Ⅱ色谱柱( 4.6 mm× 250 mm,5 μm);流动相:甲醇-水(90∶ 10);检测波长:217 nm;流速:1.0 mL·min^-1;进样量:20 μL;柱温:室温。 结果: 方法的线性范围为:10.9~163.5 μg·mL^-1,回归方程为:A=2.829×10⁴C-4.103×10⁴(r=0.9997,n=6);日内精密度RSD为1.6%(n=5),日间精密度为1.2%;回收率在97.2%~98.2%之间,RSD在0.72%~1.2%(n=9)。 结论: 方法简便灵敏,结果准确可靠,可用于重酒石酸卡巴拉汀胶囊的质量控制。

Objective: To establish an HPLC method for determining content of rivastigmine hydrogen tartrate capsules. Methods: A 5C₁₈-MS-Ⅱ column (4.6 mm ×250 mm,5 μm) was adopted at the flow rate of 1 mL· min^-1with the mobile phase of mixture of methanol and water (90∶ 10).An isocratic elution mode was carried out at the room temperature.The UV detection was at wavelength of 217 nm. Results: The calibration curve of rivastigmine showed a good linear regression within the range of 10.9-163.5 μg·mL^-1(r=0.9997,n=6).The intra-day precision of RSD was 1.6% (n=5),inter-day precision of 1.2%(n=5),The recovery was 97.2% to 98.2%,with RSD was 0.72% to 1.2%(n=9). Conclusion: The HPLC method is accurate and sensitive for determination of rivastigmine hydrogen tartrate capsules.