高效液相色谱法测定盐酸丙酰左卡尼汀片中盐酸丙酰左卡尼汀的含量

Determination of the content of propionyl L-carnitine hydrochloride in propionyl L-carnitine hydrochloride tablets by HPLC

目的建立高效液相色谱法(HPLC)用于测定盐酸丙酰左卡尼汀片中盐酸丙酰左卡尼汀的含量。方法色谱柱为Thermo Hypersil Aps-2氨基柱(4.6 mm×250 mm,5μm),流动相为0.05 mol·L^(-1)磷酸二氢钾缓冲液-乙腈(35∶65),流速1.0 mL·min^(-1),柱温30℃,检测波长205 nm。结果盐酸丙酰左卡尼汀在0.505 0~5.050 2 g·L^(-1)(r=0.9999)浓度范围内线性良好,平均加样回收率为100.1%。结论该文建立的方法专属性强、重复性好、结果准确可靠,可用于盐酸丙酰左卡尼汀片的质量控制和评价。

Objective To establish an HPLC method for determining the content of propionyl L-carnitine hydrochloride in propionyl Lcarnitine hydrochloride tablets. Methods The column was on a Thermo Hypersil Aps-2 amino column（ 4. 6 mm × 250 mm,5 μm） and0. 05 mol·L^-1 solution of potassium dihydrogen phosphate-acetonitrile（ 35∶ 65） was employed as the mobile phase. The flow rate was1. 0 mL·min^-1 with UV detection wavelength at 205 nm and the column temperature was kept at 30℃. Results The linear range of propionyl L-carnitine hydrochloride was within 0. 505 0 and 5. 050 2 g·L^-1（ r = 0. 999 9）. The average recovery was 100. 1%. Conclusion The method is of high specificity,repeatability and accuracy,and it can be used for the quality control and evaluation of propionyl-L-carnitine hydrochloride tablets.