高效液相色谱法测定氯诺昔康薄膜衣片的溶出度

Dissolution determination of lornoxicam from film-coated tablets by HPLC

目的采用高效液相色谱法法定量测定氯诺昔康薄膜衣片的溶出曲线。方法HPLC法采用ShimadzuVPODS柱(4.6mm×150mm,5μm),流动相为0.05mol·L-1醋酸钠(pH5.8)甲醇(52∶48),检测波长为379nm。溶出度测定采用中国药典2000年版二部溶出度测定法第三法装置。结果在浓度9.72～22.68mg·L-1范围内,线性方程为C=9.5628×10-5A+0.1005,r=0.9999,3种剂量组的回收率分别为99.68%(RSD0.48%),100.5%(RSD0.39%)和100.3%(RSD0.69%),重复性好,精密度高。3批样品溶出迅速,批间差异小。结论本法简单,专属性强,可准确用于氯诺昔康薄膜衣片溶出度的测定。

OBJECFIVE To establish an HPLC method for the quantitative determination of lornoxicam from film-coated tablets. METHODS The HPLC procedure was performed on Shimadzu ODS （4.6mm×150mm,5μm） column maintained. The mobile phase was the degassed mixture of sodium acetate （0.05mol·L^-1, pH 5.8） and methanol （55 ： 45）. The detection was set at 379 nm The dissolution tests were performed according to China Pharmacopoeia 2000 dissolution test apparatus Ⅲ. RESULTS The linearity range was 9. 72- 22. 68 mol·L^-1 （r= 0. 999 9）. Mean recovery was from 99. 68%to 100.5%. Precision of the method was found to be 0. 67%. Rapid dissolution of lornoxicam from three batches of film-coated tablets was observed. CONCLUSION The simple HPLC method with good specificity may be used for the accurate dissolution determination of lornoxicam film-coated tablets.