手性冠醚柱HPLC法测定盐酸伐昔洛韦分散片的含量及有关物质
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摘要
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,5μm,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11.25~180.00μg·ml-1范围内呈良好的线性关系(r=1.0000),平均回收率为99.0%,RSD为0.8%(n=9);有关物质阿昔洛韦在0.2~50μg·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。
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- 1and the detection 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. 2-50 μg·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.
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- 1and the detection 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. 2-50 μg·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.
引文
1吕扬,杜冠华.晶型药物[M].北京:人民卫生出版社,2009.15
2 USP[S].35th eds.4985
3 中国药典[S].2010年版.二部:686
4 潘斌斌.HPLC法测定盐酸伐昔洛韦胶囊含量[J].中国药师,2014,17(2):238-240
5 徐玉红,李玉珍,王蔓琳,等.RP-HPLC测定盐酸伐昔洛韦分散片的含量及有关物质[J].实用药物与临床,2007,10(2):116-118
2 USP[S].35th eds.4985
3 中国药典[S].2010年版.二部:686
4 潘斌斌.HPLC法测定盐酸伐昔洛韦胶囊含量[J].中国药师,2014,17(2):238-240
5 徐玉红,李玉珍,王蔓琳,等.RP-HPLC测定盐酸伐昔洛韦分散片的含量及有关物质[J].实用药物与临床,2007,10(2):116-118