CAJ | 학술논문

目的：建立阿托伐他汀钙片溶出度研究方法。方法色谱柱：Agilent TC-C18（4.6×250 mm，5μm）；以乙腈：四氢呋喃：0.05 M柠檬酸铵缓冲液（pH 4.0）=27：20：53为流动相；检测波长：244 nm；流速：1.5 mL·min-1；以阿托伐他汀钙与阿托伐他汀钙杂质H峰面积之和计算累积溶出量（%）；结果阿托伐他汀钙在pH 1.0盐酸溶液、醋酸-醋酸铵缓冲液（pH 4.5）中不稳定，降解生成阿托伐他汀钙杂质H，阿托伐他汀钙片在pH 1.0盐酸溶液中溶出速率最慢；结论阿托伐他汀钙在pH 1.0盐酸溶液中溶出曲线可作为处方筛选的依据。
목적：건립아탁벌타정개편용출도연구방법。방법색보주：Agilent TC-C18（4.6×250 mm，5μm）；이을정：사경부남：0.05 M저몽산안완충액（pH 4.0）=27：20：53위류동상；검측파장：244 nm；류속：1.5 mL·min-1；이아탁벌타정개여아탁벌타정개잡질H봉면적지화계산루적용출량（%）；결과아탁벌타정개재pH 1.0염산용액、작산-작산안완충액（pH 4.5）중불은정，강해생성아탁벌타정개잡질H，아탁벌타정개편재pH 1.0염산용액중용출속솔최만；결론아탁벌타정개재pH 1.0염산용액중용출곡선가작위처방사선적의거。
Objective To establish the dissolution method of atorvastatin calcium tablets. Methods Column Agilent TC-C18 (4.6×250 mm, 5μm) with mobile phase consisted of acetonitrile: tetrahydrofuran: 0.05 M ammonium citrate buffer pH 4.0 (27:20:53) at a flow rate of 1.5 mL·min-1 when the detective wavelength was set at 244 nm, plus the atorvastatin and atorvastatin related compound H peak area to calculate the cumulative release amount (%); Results Atorvastatin calcium was instable in pH 1.0 hydrochloric acid solution and acetic acid- ammonium acetate buffer (pH 4.5) and degrade to atorvastatin related compound H, the pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets was the slowest one. Conclusion The pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets can be used as the basis for formulation screening.