HPLC法测定宗胺因片中氯唑沙宗、乙水杨胺和咖啡因的溶出度

目的：建立高效液相色谱法，测定复方制剂宗胺因片的溶出度。方法：照《中国药典》2005年版（二部）溶出度测定第二法，以0．1mol·L^-1盐酸溶液1000mL为溶出介质，转速为100r·min^-1，45min时取样。以高效液相色谱法，C18柱为固定相，以甲醇-水（48：52）为流动相，检测波长：280nm。测定宗胺因片的溶出度。结果：线性范围为氯唑沙宗0．0825～0．742μg（r=0．9999）；乙水杨胺0．165—0.923μg（r=1．0000）；咖啡因0．0263～0．131μg（r=0．9999），平均回收率为氯唑沙宗100．1％（RSD％=0．4％，n=9）；乙水杨胺99．7％（RSD％=0．8％，n=9）；咖啡因99．3％（RSD％=1．2％，n=9）。结论：本方法简便、快速，专属性强。

Determination of Chlorzoxazome,Ethenzamide and Caffeine in Dissolution Test for Compound Zong'anyin Tablets by HPLC

Objective： An HPLC method was used for determination of Chorzoxzone, Ethenzamide and Caffeine in Compound Zong＇ anyin Tablet＇ s dissolution test. Method： According to Appendix X C Ⅱ of Chinese Pharmacopoeia 2005 edition Vol.Ⅱ, dissolution medi- um was 1 000 mL of 0. 1 mol · L^-1 HCl and rotating speed was 100 r · min^-1. After 60 min the dissolution Relation were taken and analyzed by HPLC method, A Kromasil C18（4. 6 mm × 150 mm,5 μm）colum was used with a mobile phase consisted of a mixture of methanol-water（48： 52）. The wavelength used for detection was 280 nm. Results：A better linearity and good correlation coefficient were obtained： Chorzoxazone was 0. 082 5 - 0. 742 μg （ r = 0. 999 9） ; Ethenzamide was 0. 165 - 0. 823 μg （ r = 1. 000 0） ; Caffeine was 0. 026 3-0. 13 1 μg（r =0. 999 9）. The satisfactory recoveries were obtained： Chorzoxazone was 100. 1% （RSD% =0. 4% ） ;Ethenzamide was 99. 7% （RSD% =0. 8% ） ;Caffeine was 99. 3% （RSD% = 1.2% ）. Conclusion：The method was convenient and accurate. It can be used as a method of quality control.