摘要
目的:建立测定利培酮口服液中主药含量的方法。方法:采用高效液相色谱法。色谱柱为Hypersil BDS-C18柱,流动相为乙腈-0.5%醋酸铵溶液(用三乙胺调pH值至7.0,22:78,V/V),流速为1.5ml/min,检测波长为275nm,柱温为40℃,进样量为10μl。结果:利培酮检测质量浓度在0.16～0.24mg/ml范围内与峰面积积分值呈良好的线性关系(r=0.9996);精密度、稳定性、重复性试验的RSD均≤0.7%;平均回收率为99.5%,RSD=0.6%(n=9)。结论:该法专属性强、灵敏度高、简便易行、结果准确,适用于利培酮口服液中主药的含量测定。
OBJECTIVE： To establish a method for the content determination of main component in Risperidone oral solution. METHODS： HPLC method was adopted. The separation was performed on Hypersil BDS-C18 column with mobile phase consisted of acetonitrile-0.5% ammoninm acetate （pH adjusted to 7.0 with triethylamine, 22：78, V/V） at the flow rate of 1.5 ml/min. The de- tection wavelength was set at 275 nm and column temperature was 40 ℃. The sample size was 10 μl. RESULTS： The linear range of risperidone was 0.16-0.24 mg/ml （r=0.999 6） with an average recovery of 99.5% （RSD=0.6%, n=9）. RSDs of precisions, stability and reproducibility tests were lower than and equal to 0.7%. CONCLUSIONS： The method is specific, sensitive, simple and accurate, and it can be used for the content determination of main components in Risperidone oral solution.
出处
《中国药房》
CAS
CSCD
2013年第24期2283-2284,共2页
China Pharmacy
