CAJ | 학술논문

目的:建立高效液相色谱法测定阿托伐他汀钙片的溶出度.方法:使用整体化色谱柱,乙腈-0.1%磷酸溶液梯度洗脱、紫外检测器测定阿托伐他汀钙片的溶出度.并对高效液相色谱法进行了系统的方法学验证.结果:建立的方法符合测定要求,采用高效液相色谱法和紫外分光光度法测定阿托伐他汀钙片的溶出度结果一致.自制片剂与原研产品具有相同的溶出曲线.结论:所建立的高效液相适用于测定阿托伐他汀钙片的溶出度.
목적:건립고효액상색보법측정아탁벌타정개편적용출도.방법:사용정체화색보주,을정-0.1%린산용액제도세탈、자외검측기측정아탁벌타정개편적용출도.병대고효액상색보법진행료계통적방법학험증.결과:건립적방법부합측정요구,채용고효액상색보법화자외분광광도법측정아탁벌타정개편적용출도결과일치.자제편제여원연산품구유상동적용출곡선.결론:소건립적고효액상괄용우측정아탁벌타정개편적용출도.
ABSTRACT Objective: To establish an HPLC method for the determination of dissolution of atorvastatin calcium tablets. Methods: The chromatographic separation was performed on a monolithic column by gradient elution with a mixture of acetonitrile-0.1% phosphoric acid solution as a mobile phase. Atorvastatin calcium tablets were determined by HPLC with ultraviolet detection. HPLC method was systematically validated. Results: The results obtained by HPLC and UV methods are consistent. The dissolution curve of the self-made atorvastatin calcium tablets is similar to that of the original one. Conclusion:HPLC method is suitable for the determination of dissolution of atorvastatin calcium tablets.