左旋盐酸苯环壬酯片的含量及溶出度测定方法

目的：测定左旋盐酸苯环壬酯片的含量及溶出度。方法：采用溶剂萃取酸性色素比色法（BCG法）测定含量,λmax=414nm。溶出度以桨法测定,转速50r·min^-1,溶出介质为250mL0.1mol·L^-1盐酸溶液。结果：当左旋盐酸苯环壬酯浓度为2.0～10.0μg·mL^-1时,浓度与吸光度呈良好线性,回归方程：Y=0.0935X＋0.0021,R^2=1（n=3）,回收率为（98.76±1.55）%,RSD=1.57%（n=5）。片剂30min取样,主药溶出80%以上。结论：该方法简便、快捷、准确,与HPLC法含量测定结果基本一致,为该制剂的溶出度测定及片剂半成品快速测定提供了方法学依据。

Determination of the content and dissolution of left-levophencynonate hydrochloride tablets

Objective：To determine the content and dissolution of left-levophencynonate hydrochloride tablets（L-LPC）.Methods：A solvent extraction-acid dye spectrophotometry method was used,with the detection wavelength was 414 nm.An oar method was used to study the dissolution of L-LPC tablets,the rotative speed was 50 r·min^-1 and the dissolution medium was 250 mL of hydrochloric acid solution（0.1 mol·L^-1）.Results：The linear range of the standard curve was 2.0 ～ 10.0 μg · mL^-1,and the regression equation was Y = 0.093 5X ＋ 0.002 1,R2 = 1（n = 3）.The average recovery of the assay was（98.76 ± 1.55）%,RSD = 1.57%（n = 5）.The drug dissolution rate was over 80% at 30 min.Conclusion：This method is convenient,accurate and specific for dissolution determination of L-LPC tablets and provided basis for fast determination of semi-product.