医药前沿
醫藥前沿
의약전연
YIAYAO QIANYAN
2013年
18期
71-72
,共2页
钱小平%毕秀玲%栾爽%赵迎春
錢小平%畢秀玲%欒爽%趙迎春
전소평%필수령%란상%조영춘
乙胺吡嗪利福异烟片Ⅱ%溶出度%高效液相色谱
乙胺吡嗪利福異煙片Ⅱ%溶齣度%高效液相色譜
을알필진리복이연편Ⅱ%용출도%고효액상색보
Rifampicin Isoniazid Pyrazinamide and Ethambutol hydrochloride Tablets Ⅱ%dissolution%HPLC
目的对乙胺吡嗪利福异烟片Ⅱ的溶出度测定方法进行改进。方法色谱柱为Kromasil C18(5μm,4.6mmI.D.×150mm),流动相为磷酸盐缓冲液-乙腈梯度洗脱,检测波长为238nm,流速为1.5mL?min-1,进样量为20μL。结果利福平在0.1279 mg?mL-1~0.1918mg?mL-1,异烟肼在0.06360 mg?mL-1~0.09540 mg?mL-1,吡嗪酰胺在0.3435 mg?mL-1~0.5153mg?mL-1范围内线性关系良好。平均回收率为利福平98.3%,异烟肼100.0%,吡嗪酰胺99.8%。RSD为利福平0.4%,异烟肼0.4%,吡嗪酰胺0.8%。结论该方法专属性强,稳定性好,准确度高,可用于乙胺吡嗪利福异烟片Ⅱ的溶出度检查。
目的對乙胺吡嗪利福異煙片Ⅱ的溶齣度測定方法進行改進。方法色譜柱為Kromasil C18(5μm,4.6mmI.D.×150mm),流動相為燐痠鹽緩遲液-乙腈梯度洗脫,檢測波長為238nm,流速為1.5mL?min-1,進樣量為20μL。結果利福平在0.1279 mg?mL-1~0.1918mg?mL-1,異煙肼在0.06360 mg?mL-1~0.09540 mg?mL-1,吡嗪酰胺在0.3435 mg?mL-1~0.5153mg?mL-1範圍內線性關繫良好。平均迴收率為利福平98.3%,異煙肼100.0%,吡嗪酰胺99.8%。RSD為利福平0.4%,異煙肼0.4%,吡嗪酰胺0.8%。結論該方法專屬性彊,穩定性好,準確度高,可用于乙胺吡嗪利福異煙片Ⅱ的溶齣度檢查。
목적대을알필진리복이연편Ⅱ적용출도측정방법진행개진。방법색보주위Kromasil C18(5μm,4.6mmI.D.×150mm),류동상위린산염완충액-을정제도세탈,검측파장위238nm,류속위1.5mL?min-1,진양량위20μL。결과리복평재0.1279 mg?mL-1~0.1918mg?mL-1,이연정재0.06360 mg?mL-1~0.09540 mg?mL-1,필진선알재0.3435 mg?mL-1~0.5153mg?mL-1범위내선성관계량호。평균회수솔위리복평98.3%,이연정100.0%,필진선알99.8%。RSD위리복평0.4%,이연정0.4%,필진선알0.8%。결론해방법전속성강,은정성호,준학도고,가용우을알필진리복이연편Ⅱ적용출도검사。
Objective: To improve dissolution of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol hydrochloride Tablets Ⅱ.Methods: Chromatography was performed on the Kromasil C18(5μm,4.6mmI.D.×150mm),using phosphate buffer and acetonitrile to elute gradiently as the mobile phase, the detection wavelength was 238nm, the flow rate was 1.5mL?min-1, the injection volume was 20 μL. Results: The linear ranges were 0.1279~0.1918mg?mL-1 for Rifampicin, 0.06360~0.09540mg?mL-1 for Isoniazid and 0.3435~0.5153mg?mL-1 for Ethambutol hydrochloride, the recovery were 98.3% for Rifampicin, 100.0% for Isoniazid and 99.8% for Ethambutol hydrochloride, RSD were 0.4% for Rifampicin, 0.4% for Isoniazid and 0.8% for Ethambutol hydrochloride. Conclusion: The method is specified, stable, with good accuracy, which can be used for dissolution of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol hydrochloride Tablets Ⅱ.