中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
12期
64-66
,共3页
高效液相色谱法%盐酸法舒地尔%原料药%注射液%含量测定
高效液相色譜法%鹽痠法舒地爾%原料藥%註射液%含量測定
고효액상색보법%염산법서지이%원료약%주사액%함량측정
HPLC%fasudil hydrochloride%Fasudil Hydrochloride Injection%content determination
目的：采用高效液相色谱（HPLC）法测定盐酸法舒地尔原料药及注射液的含量。方法采用 Phenomenex Prodigy ODS C18（2）100A (150 mm ×4.6 mm，5μm)色谱柱，以1.0％三乙胺水溶液（用磷酸调 pH 至7.0）-甲醇（50：50）为流动相，流速为0.8 mL / min，柱温为40℃，检测波长为275 nm，进样量为20μL。结果盐酸法舒地尔质量浓度在3～60μg / mL 范围内与其峰面积呈良好线性关系，线性方程为 A ＝1.93×104 C -1.73×103，r ＝0.9999（ n ＝7）；平均回收率为99.50％，RSD 为0.87％（ n ＝9）。结论该方法简便、精密、回收率高，重现性好，可用于盐酸法舒地尔原料药及注射液的含量测定。
目的：採用高效液相色譜（HPLC）法測定鹽痠法舒地爾原料藥及註射液的含量。方法採用 Phenomenex Prodigy ODS C18（2）100A (150 mm ×4.6 mm，5μm)色譜柱，以1.0％三乙胺水溶液（用燐痠調 pH 至7.0）-甲醇（50：50）為流動相，流速為0.8 mL / min，柱溫為40℃，檢測波長為275 nm，進樣量為20μL。結果鹽痠法舒地爾質量濃度在3～60μg / mL 範圍內與其峰麵積呈良好線性關繫，線性方程為 A ＝1.93×104 C -1.73×103，r ＝0.9999（ n ＝7）；平均迴收率為99.50％，RSD 為0.87％（ n ＝9）。結論該方法簡便、精密、迴收率高，重現性好，可用于鹽痠法舒地爾原料藥及註射液的含量測定。
목적：채용고효액상색보（HPLC）법측정염산법서지이원료약급주사액적함량。방법채용 Phenomenex Prodigy ODS C18（2）100A (150 mm ×4.6 mm，5μm)색보주，이1.0％삼을알수용액（용린산조 pH 지7.0）-갑순（50：50）위류동상，류속위0.8 mL / min，주온위40℃，검측파장위275 nm，진양량위20μL。결과염산법서지이질량농도재3～60μg / mL 범위내여기봉면적정량호선성관계，선성방정위 A ＝1.93×104 C -1.73×103，r ＝0.9999（ n ＝7）；평균회수솔위99.50％，RSD 위0.87％（ n ＝9）。결론해방법간편、정밀、회수솔고，중현성호，가용우염산법서지이원료약급주사액적함량측정。
Objective To establish a HPLC method to determine the content of fasudil hydrochloride raw material drug and Fasudil Hy-drochloride Injection. Methods The Phenomenex Prodigy ODS C18(2) 100A column (150 × 4. 6mm,5μm) was adopted,the mobile phase was 1. 0% - triethylamine aqueous solution(adjusting to pH 7. 0 with phosphoric acid)- methanol(50 : 50),the flow rate was 0. 8 mL / min,the column temperature was 40℃ and detecting wave length was 275 nm. Results The mass concentration of fasudil hy-drochloride in the range of 3 - 60 μg / mL( r = 0. 999 9,n = 7)had good linear correlation with the area of the test peak,the linear e-quation was A = 1. 93 × 104 C - 1. 73 × 103,r = 0. 999 9( n = 7);the average recovery rate was 99. 49%( n = 9,RSD = 0. 8% ). Conclusion The method is simple and precise with high recovery rate and good reproducibility,which can be used for the determination of the con-tent of fasudil hydrochloride raw material drug and Fasudil Hydrochloride Injection.
