摘要
目的应用HPLC法测定盐酸索他洛尔氯化钠注射液中盐酸索他洛尔的含量。方法色谱柱为依利特Kromaisl C18（5μm,4.6 mm×250 mm）,流动相为乙腈-0.2%庚烷磺酸钠溶液（21∶79）（用磷酸调节pH至3.0）,流速为1.0 ml/min,检测波长为228 nm,柱温为室温。结果盐酸索他洛尔在0.081~0.324 mg/ml范围内,浓度与峰面积线性关系良好（r=0.9999）;平均回收率为98.76%,RSD为0.97%（n=9）。精密度试验RSD为0.78%（n=6）。结论该方法测定结果准确、灵敏、可靠。
Objective To establish an HPLC method for determination of sotalol hydrochloride in sotalol hydrochloride and sodium chloride injection.Methods The determination was performed by HPLC on Kromasil C18 column（5 μm,4.6mm×250mm）using acetonitrile-0.2% solution of heptane sulfonate（adjusted to pH 4.5 with phosphate）（21：79）as mobile phase.The flow rate was 1.0 ml/min,the detection wavelength was 228nm and column temperature was room temperature.Results The calibration curve was liner in the range of 0.081～0.324mg/ml（r=0.9999）.Conclusion The method is accurate,sensitive and reliable.
出处
《淮海医药》
CAS
2010年第4期310-311,共2页
Journal of Huaihai Medicine
