HPLC法检测注射用酒石酸吉他霉素中吉他霉素各组分含量

Study on Contents Determination Methodology of Kitasamycinum Composition in Kitasamycin Tartrate for Injection by HPLC

目的:建立HPLC测定注射用酒石酸吉他霉素中吉他霉素各组分含量的方法。方法:色谱条件:采用Thermo ODS-2 C18(150 mm×4.6 mm,5μm)为色谱柱,以0.1 mol/L醋酸铵溶液-甲醇-乙腈(40∶55∶5)为流动相;检测波长为231 nm。结果:吉他霉素各组分在1.3～4.4 mg/mL(以吉他霉素计)范围内各组分峰面积与浓度呈良好的线性关系(r=0.9990～0.9998)。结论:该方法简便,结果准确、重现性好,可用于注射用酒石酸吉他霉素的质量控制。

Objective To develop a HPLC method for determining the contents of kitasamycinum compositions in kitasamycin tartrate for injection.Methods The analysis was performed on a Thermo ODS-2 C18 column(150 mm×4.6 mm,5 μm).The mobile phase was consisted with 0.1 mol/L ammonium acetate-methanol-acetonitrile(40∶55∶5).The detective wavelength was 231 nm.Results The linear range for kitasamycinum composition was from 1.3 to 4.4 mg/mL(r=0.9990 to 0.9998,calculated by kitasamycinum).Conclusion The method was simple,accurate and reproducible.