固相反应器流动注射在线氧化荧光法测定艾司唑仑片剂含量及溶出度

Determination of content and dissolution of estazolam tablets by flow injection spectrofluorometry with solid-phase reactor

目的:建立流动注射荧光法测定艾司唑仑片剂含量及其溶出度的新方法。方法:利用二氧化铅固相反应器在线氧化艾司唑仑为强荧光化合物,流动注射荧光法测定艾司唑仑含量;以中国药典溶出度测定的溶出条件,建立自动采样、测定的溶出度测定方法。结果:艾司唑仑浓度在5×10^(-8)～1×10^(-5)·mL^(-1)范围内呈良好的线性关系(r=0.999),检出限为1.0×10^(-8)·mL^(-1)。片剂中艾司唑仑20 min 溶出量不少于标示量的75%。结论:该法灵敏度高、快速、简便、准确,含量测定结果与中国药典法一致;适用于片剂中艾司唑仑含量的测定及自动、快速的药物溶出度测定。

Objective：To establish a new method to determine the content and dissolution of estazolam tablets by flow injection spectrofluorometry. Methods：Estazolam was oxidized on - line into a strongly fluorescent compound with a lead dioxide solid - phase reactor, then the content of estazolam was determined with a fluorimetric detector in flow injection system. The developed flow injection fluorimetric method was adopted for the determination of dissolution of estazolam tablets according to dissolution qualification of Chinese pharmacopoeia. Results： The calibration curve was linear over a range from 5 × 10^-8 to 1 × 10^-5 g · mL^-1 of estazolam with a regression efficient of 0. 999. The detection limit was 1.0 × 10^-8g · mL^-1 ;the dissolution was not less than 75% of labelled amount at 20 min. Conclusion： This method is automatic, rapid, simple and accurate, and is suitable for the determination of content and dissolution of estazolam tablets.