Determination of Lysine Hydrochloride in Pediatric Compound Lysine Granule by an Amino Acid Analyzer / 中国药师

ABSTRACT

Objective:To establish a quantitative method for the determination of lysine hydrochloride in pediatric compound lysine granules. Methods:The quantitative determination was performed on an amino acids analyzer. The cationic resin column(150 mm × 4. 6 mm,7 μm)was used. The mobile phase was citrate buffer solution (pH 3. 45) and citrate buffer solution (pH 10. 85) with gradient elution at a flow rate of 0. 45 ml·min-1 . The detection wavelengths were set at 570 nm and 440 nm. Results:The linear range of lysine hydrochloride was 2. 692-21. 536 μg·ml-1(r=0. 999 5), and the average sample recovery was 98. 85% with RSD of 0. 63% (n=9). Conclusion:The method is sensitive, simple and reproducible. It can be used for the quality control of pediatric compound lysine gran-ules.