紫外分光光度法测定盐酸头孢替安酯片溶出度的方法

The method for determination of dissolution rate of cefotiam hexetil hydrochloride tabletsby UV spectrophotometry

目的:采用紫外分光光度法建立盐酸头孢替安酯片溶出度的测定方法。方法:按中国药典(2010年版)二部附录X C第二法(桨法),以pH4.0醋酸-醋酸钠缓冲液900ml为溶出介质,转速为100转/min,45分钟取样;按紫外分光光度法,于258nm的波长处测定其溶出度。结果:盐酸头孢替安酯在13.0～39.0μg/ml范围内线性关系良好(r=0.9999);平均回收率(n=9)为99.3%,RSD为0.7%。结论:本方法准确、可靠、灵敏度高,适用于盐酸头孢替安酯片溶出度的检测。

Objective：To establish a method for determination of dissolution rate of cefotiam hexetil hydrochloride tablets by UV spectrophotometry. Methods： According to ChP. 2010. Vol II Appendix X C method 2, using 900ml of acetic acid - sodium acetate buffer（pH4.0） as the dissolution medium, adjusted the rotational speed of the paddle to 100 rpm, withdrew a quantity of the solution at exact 45 minutes, measured the absorbance at 258nm by UV spectrophotometry, calculated the dissolution rate. Results： The calibration curve showed a good linearity in the range of 13.0 - 39.0μg/ml （ r = 0. 9999 ） ; The average recovery （ n = 9 ） was 99.3 %, RSD was 0.7 %. Conclusion： The method is accurate, reliable and sensitive, and can be applied for determination of dissolution rate of cefotiam hexetil hydrochloride tablets.