紫外检测器—高效液相色谱法测定复方氨基酸注射液中山梨醇含量的研究

Determination of Sorbitol in compound amino injection(18AA)using UV Detector-HPLC(UV-HPLC)method

目的建立复方氨基酸注射液(18AA)中山梨醇含量的测定方法。方法通过系统适用性试验、线性试验、回收试验、重复性试验、溶液稳定性试验验证紫外检测器—高效液相色谱法(UV-HPLC法)测定18AA中山梨醇含量的精确性。并比较采用过树脂后高碘酸盐法和UV-HPLC法测定3批试制样品中山梨醇含量的结果。结果 UV-HPLC法回收率、线性和重复性良好,溶液稳定。结论 UV-HPLC法能准确测定18AA中山梨醇的含量。

Objective To established the method of determination of Sorbitol in 18AA. Methods After System Suit-ability Testing, recovery testing, linearity testing, repeatability testing and sample stability testing, UV-HPLC method was valida- ted that it could determine Sorbitol in 18AA accurately;Sorbitol assay of 3 batches of 18AA using UV-HPLC method and the national drug standards （Compound amino acid injection 18AA） had been carried out simultaneously. Results The recovery, linearity, repeatability and sample stability could meet the requirments. Conclusion UV-HPLC method can test the content of Sorbitol inlSAA accurately.