中国药师
中國藥師
중국약사
China Pharmacist
2015年
10期
1678-1681
,共4页
高效液相色谱法%手性冠醚柱%盐酸伐昔洛韦%含量测定%有关物质
高效液相色譜法%手性冠醚柱%鹽痠伐昔洛韋%含量測定%有關物質
고효액상색보법%수성관미주%염산벌석락위%함량측정%유관물질
HPLC%Crownpak CR( +)%Valacyclovir hydrochloride%Content%Related substances
目的:建立手性冠醚柱高效液相色谱法测定盐酸伐昔洛韦分散片的含量及其有关物质的方法,为质量标准的提高提供参考. 方法:采用手性冠醚柱[4. 0 mm × 150 mm,5 μm,DAICEL CROWNPAK CR( +)],流动相为0. 1%高氯酸溶液,流量为0. 75 ml·min-1,检测波长为255 nm. 结果:盐酸伐昔洛韦在11. 25~180. 00 μg·ml-1范围内呈良好的线性关系(r=1. 000 0),平均回收率为99.0%,RSD 为0.8%(n =9);有关物质阿昔洛韦在0.2 ~50 μg·ml-1范围内呈良好的线性关系(r =1. 000 0),平均回收率为99. 3%,RSD为0. 6%(n=9);收集的两家企业的盐酸伐昔洛韦分散片含量测定结果分别为92. 7%、97. 4%,有关物质阿昔洛韦按外标法计算结果分别为0. 5%、0. 4%,D-伐昔洛韦按自身对照法计算结果均为0. 9%. 结论: 该方法能有效分离伐昔洛韦及其同分异构体D-伐昔洛韦,简便、准确,专属性强,适用于盐酸伐昔洛韦的质量控制.
目的:建立手性冠醚柱高效液相色譜法測定鹽痠伐昔洛韋分散片的含量及其有關物質的方法,為質量標準的提高提供參攷. 方法:採用手性冠醚柱[4. 0 mm × 150 mm,5 μm,DAICEL CROWNPAK CR( +)],流動相為0. 1%高氯痠溶液,流量為0. 75 ml·min-1,檢測波長為255 nm. 結果:鹽痠伐昔洛韋在11. 25~180. 00 μg·ml-1範圍內呈良好的線性關繫(r=1. 000 0),平均迴收率為99.0%,RSD 為0.8%(n =9);有關物質阿昔洛韋在0.2 ~50 μg·ml-1範圍內呈良好的線性關繫(r =1. 000 0),平均迴收率為99. 3%,RSD為0. 6%(n=9);收集的兩傢企業的鹽痠伐昔洛韋分散片含量測定結果分彆為92. 7%、97. 4%,有關物質阿昔洛韋按外標法計算結果分彆為0. 5%、0. 4%,D-伐昔洛韋按自身對照法計算結果均為0. 9%. 結論: 該方法能有效分離伐昔洛韋及其同分異構體D-伐昔洛韋,簡便、準確,專屬性彊,適用于鹽痠伐昔洛韋的質量控製.
목적:건립수성관미주고효액상색보법측정염산벌석락위분산편적함량급기유관물질적방법,위질량표준적제고제공삼고. 방법:채용수성관미주[4. 0 mm × 150 mm,5 μm,DAICEL CROWNPAK CR( +)],류동상위0. 1%고록산용액,류량위0. 75 ml·min-1,검측파장위255 nm. 결과:염산벌석락위재11. 25~180. 00 μg·ml-1범위내정량호적선성관계(r=1. 000 0),평균회수솔위99.0%,RSD 위0.8%(n =9);유관물질아석락위재0.2 ~50 μg·ml-1범위내정량호적선성관계(r =1. 000 0),평균회수솔위99. 3%,RSD위0. 6%(n=9);수집적량가기업적염산벌석락위분산편함량측정결과분별위92. 7%、97. 4%,유관물질아석락위안외표법계산결과분별위0. 5%、0. 4%,D-벌석락위안자신대조법계산결과균위0. 9%. 결론: 해방법능유효분리벌석락위급기동분이구체D-벌석락위,간편、준학,전속성강,괄용우염산벌석락위적질량공제.
Objective:To establish a Crownpak CR( +)-HPLC method for the determination of the content and related substance of valacyclovir hydrochloride dispersible tablets. Methods: A Crownpak CR( +) [4. 0 mm × 150 mm,5 μm,DAICEL CROWNPAK CR( +)] column was used,and the mobile phase was 0. 1% perchloric acid in water. The flow rate was 0. 75 ml·min-1 and the de-tection wavelength was 255 nm. Results: A good linear range of valacyclovir hydrochloride was 11. 25-180. 00 μg · ml-1 ( r =1. 000 0), and the average recovery was 99. 0%(RSD=0. 8%, n=9). A good linear range of alacyclovir was 0. 2-50μg·ml-1(r=1. 000 0), and the average recovery was 99. 3%(RSD=0. 6%, n=9). The content of the tablets from two pharmaceutical companies was 92. 7% and 97. 4%, respectively, that of acyclovir calculated by an external standard method was 0. 5% and 0. 4%, respectively, and that of D-valacyclovir calculated by a self-control method was 0. 9%. Conclusion:The method can effectively separate valacyclovir and D-valacyclovir, which is simple, accurate and reliable, and suitable for the quantity control of valacyclovir hydrochloride.
