Qu X Y, He C F, Sun L J, Wang X, Luo X
Shenyang College of Pharmacy.
Yao Xue Xue Bao. 1990;25(3):198-203.
A rapid spectrophotometric method based on FIA for the content uniformity test of atropine sulfate tablets has been developed. By means of the self-designed FIA system with an on-line extraction device, many difficulties resulting from extraction, such as slow analytical rate, environmental pollution, poor reproducibility, etc, were overcome, and the routine procedure of the official content uniformity test was tremendously simplified. Results obtained with the proposed method agree well with those obtained with the official test. Furthermore, the proposed method attained a sampling rate of 60 samples per hour, a recovery of 100.0%, a relative standard deviation of 0.7%, and a detection limit of 0.24 micrograms/ml. Uniform design proves effective to optimize complex FIA conditions, and FIA promises a new approach to test the content uniformity of pharmaceutical tablets.
建立了一种基于流动注射分析(FIA)的快速分光光度法用于硫酸阿托品片的含量均匀度检查。通过自行设计的带有在线萃取装置的流动注射分析系统,克服了萃取过程中存在的诸多难题,如分析速度慢、环境污染、重现性差等,极大地简化了法定含量均匀度检查的常规操作程序。该方法所得结果与法定检查方法的结果吻合良好。此外,该方法的进样速度达到每小时60个样品,回收率为100.0%,相对标准偏差为0.7%,检测限为0.24微克/毫升。均匀设计被证明能有效地优化复杂的流动注射分析条件,流动注射分析为药物片剂含量均匀度检查提供了一种新方法。