摘要
目的采用高效液相色谱法与紫外分光光度法测定复方利福平微丸胶囊溶出度的方法。方法异烟肼与吡嗪酰胺色谱柱AlltechAlltimaCN(5μm,250mm×4.6mm);柱温30℃;流动相0.01mol/L庚烷磺酸钠溶液(用稀磷酸调节pH至2.0)-乙腈(44∶56);流速1.0ml/min;检测波长254nm;检测灵敏度为0.1aufs,进样量10μl。利福平紫外分光光度法,测定波长474nm。结果异烟肼在1～22μg/ml浓度范围内,峰面积与其浓度线性关系良好,r=0.9999,平均回收率为99.3%;吡嗪酰胺在3～58μg/ml浓度范围内,峰面积与其浓度线性关系良好,r=0.9999,平均回收率为99.6%;重复性试验RSD均小于1.5%(n=9)。利福平在2～50μg/ml浓度范围内,吸收度与其浓度线性关系良好,r=0.9996,平均回收率为99.5%。结论本方法快速简便,精密度好,灵敏度高,可作为控制复方利福平微丸胶囊溶出度与释放度的方法。
Objective A high performance liquid chromatography and UV method was established to determine the dissolutions of rifampicin compound micropill capsules. Method Isoniazid and pyrazinamide-The analytical column was Alltech Alltima CN (250×4.6mm,5μm). The column temperature was 30℃. The mobile phase was consisted of the 0.01mol/L sodium heptanesulfonate solution (pH2.0)-acetonitrile (44∶56). The flow rate was 1.0 ml/min. The detection wavelength was 254 nm. The detection sensitivity was 0.1 aufs and the injection volume was 10μl. The detection wavelength was 474nm. Results The calibration curve for isoniazid was linear in the range from 1μg/ml to 22μg/ml, r=0.9999. The average recovery was 99.3%. The calibration curve for pyrazinamide was linear in the range from 3μg/ml to 58μg/ml, r=0.9999. The average recovery was 99.6%. The calibration curve for rifampicin was linear in the range from 2μg/ml to 50μg/ml, r=0.9996. The average recovery was 99.5%, and RSD was within 1.5%. Conclusion The method is simple, rapid, accurate and reproducible, and can be used for the drug control.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2004年第12期752-754,759,共4页
Chinese Journal of Antibiotics
关键词
复方利福平微丸胶囊
溶出度测定
HPLC
Rifampicin compound micropill capsules
Dissolution determination
HPLC
