摘要
建立了高效液相色谱法测定左卡尼汀注射液含量。采用Zorbax SB—C18色谱柱(4.6 mm×250 mm,5μm),流动相为磷酸盐缓冲液[(取磷酸11.5 mL,加水约1800 mL,用1 mol/L氢氧化钠溶液调节至pH3.0,加水至2 000 mL),加庚烷磺酸钠1.1 g,振摇使溶解]—甲醇(95∶5),流速1.0 mL.min-1,检测波长为225 nm。结果表明,在0.04～3.0 mg/mL的范围内,浓度与峰面积之间呈现良好线性关系,r2=0.999 8(n=7),左卡尼汀注射液含量为标示量98.46%～100.9%,平均回收率为99.78%(n=9)。该法简便、准确、专属,可用于该注射液的质量控制。
A method was established to determine the content of Levocarnitine injection by HPLC.The Zorbax SB-C18 column（4.6 mm×250 mm,5 μm）was used,phosphate buffer solution[（11.5 mL phosphoric acid was dissolved in 1 800 mL water,adjusted to pH 3.0 with 1 mol·L-1 sodium hydroxide solution,and bring up to full volume 2 000 mL with water）,1.1 g sodium heptanesulfonate was added and dissolved by shaking]： methanol（95∶5） as mobile phase,at a flow rate of 1.0 mL·min-1,at detection wavelength 225 nm.As a result,the linearity of peak area was good when the injected quantity of Levocarnitine was in the range of 0.04～3.0 mg·mL-1（r=0.999 9,n=6）.The recovery of the method was 99.78%,the content of Levocarnitine injection was 98.46%～100.9%.It can be concluded that the method is specific,accurate and convenient,and can be used for quality control of the Levocarnitine injection.
出处
《科学技术与工程》
2011年第30期7494-7496,7503,共4页
Science Technology and Engineering
