中国药业2012，Vol.21Issue(24)：43-44,2.
盐酸丙酰左卡尼汀注射剂中有关物质及含量的测定
Determination of Three Related Substances and Their contents in Propionyl Levocarnitine Hydrochloride Injection by HPLC
沈小钟 1杨帆 2杨燕军 3张现涛1
作者信息
- 1. 广东食品药品职业学院,广东,广州,510520
- 2. 暨南大学药学院,广东,广州,510632
- 3. 重庆市食品,药品检验所,重庆,401121
- 折叠
摘要
Abstract
Objective To establish a HPLC method for determining the related substances and their contents in propionyl levocarnitine hydrochloride Injection. Methods The HPLC analysis was carried out on the Zorbax SB-Cis column (250 mm×4. 6 mm,5 μm) kept at the column temperature of 35℃ ,with the mobile phases consisting of 0. 006 mol/L octanesulfonic acid sodium solution (adding 10 mL triethylamine per 1 000 mL water, adjusting to pH 2.9 with phosphoric acid )-methanol (95:5, V/ V) The flow rate was 1.0 mL/min. The detection wavelength was 210 nm using the photodiode array (PDA) detector. Results The main peak and adjacent impurity peaks were completely separated. The mass concentration in the range of 1.003 6-20. 072 g/L showed the good linear relationship with the peak area(r=0.999 8,n = 5).The average recovery rate was 99. 71% , RSD = 1. 26% (n = 9).The lowest detection limit was 0.038 88 g/L. Conclusion This method is simple and sensitive with strong specificity and accurate detection results,and suitable for the determination of propionyl levocarnitine hydrochloride Injection and its related substances.关键词
高效液相色谱法/盐酸丙酰左卡尼汀/有关物质Key words
HPLC/propionyl levocarnitine hydrochloride/related substances分类
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沈小钟,杨帆,杨燕军,张现涛..盐酸丙酰左卡尼汀注射剂中有关物质及含量的测定[J].中国药业,2012,21(24):43-44,2.
