CAJ | 학술논문

建立利用19 F核磁共振定量技术测定阿托伐他汀钙含量的方法.通过测定不同弛豫延迟时间、扫描次数以及内标物质对测定结果的影响,确定了19 F核磁共振定量试验中适宜的仪器参数设置以及内标物质选择.在中心频率为-115×10-6,谱宽为60×10-6,弛豫延迟时间为10 s,扫描次数为16次的情况下,以氟伐他汀钠为内标,测定出阿托伐他汀钙的质量分数ws 为96.2%.试验重复3次,相对标准偏差 RSD为0.4%,证明试验的重复性比较好.利用质量平衡法测定阿托伐他汀钙质量分数ws 为95.3%,与19 F核磁共振定量技术得到的结果接近.证明19 F核磁共振定量技术可以快速、准确地测定阿托伐他汀钙的绝对含量用于阿托伐他汀钙的质量控制.
건립이용19 F핵자공진정량기술측정아탁벌타정개함량적방법.통과측정불동이예연지시간、소묘차수이급내표물질대측정결과적영향,학정료19 F핵자공진정량시험중괄의적의기삼수설치이급내표물질선택.재중심빈솔위-115×10-6,보관위60×10-6,이예연지시간위10 s,소묘차수위16차적정황하,이불벌타정납위내표,측정출아탁벌타정개적질량분수ws 위96.2%.시험중복3차,상대표준편차 RSD위0.4%,증명시험적중복성비교호.이용질량평형법측정아탁벌타정개질량분수ws 위95.3%,여19 F핵자공진정량기술득도적결과접근.증명19 F핵자공진정량기술가이쾌속、준학지측정아탁벌타정개적절대함량용우아탁벌타정개적질량공제.
Quantitative 19 F NMR was used to characterize content of Atorvastatin calcium.Suitable instrument settings and internal standard for quantitative 19F NMR were determined.With O1P is -115× 10-6 ,SW is 60×10-6 ,D1 is 10 s,NS is 16 and fluvastatin sodium as internal standard,atorvastatin calcium content was found to be 9 6.2%.Three repeated experiments showed an RSD of 0.40%.Confirmation with mass balance method found atorvastation calcium content to be 95.2%,indicating high consistence between quantitative 19 F NMR and mass balance method.Quantitative 19 F NMR can measure atorvastatin calcium content quickly and precisely.