HPLC法测定磷酸伯氨喹片的含量及均匀度

目的:建立测定磷酸伯氨喹片含量及均匀度的方法。方法:采用高效液相色谱法。色谱柱为Inertsil C8,流动相为水-乙腈-四氢呋喃-三氟乙酸(90∶9∶1∶0.1,V/V/V/V),检测波长为265 nm,流速为1.5 ml/min,柱温为40℃,进样量为10μl。结果:磷酸伯氨喹检测质量浓度在128.069³84.206μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9);精密度、稳定性、重复性试验的RSD≤0.5%;平均加样回收率为100.6%,RSD=0.3%(n=9);含量均匀度的A+1.80S在7.3384.206μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9);精密度、稳定性、重复性试验的RSD≤0.5%;平均加样回收率为100.6%,RSD=0.3%(n=9);含量均匀度的A+1.80S在7.3¹1.3之间。结论:该方法操作简单、准确性高、专属性强,适用于磷酸伯氨喹片的质量控制。

Content Determination and Content Uniformity of Primaquine Phosphate Tablets by HPLC

OBJECTIVE： To establish the method for content determination and content tmiformity of Primaquine phosphate tablets. METHODS： HPLC method was adopted. The determination was performed on Inertsil C8 column with mobile phase consisted of water-acetonitrile-tetrahydrofuran-trifluoroacetic acid （90 ： 9 ： 1：0.1, V/V/V/V） at flow rate of 1.5 ml/min. The detection wave- length was set at 265 nm and column temperature was 40℃. The injection volume was 10 ul. RESULTS ： The linear range of primaquine phosphate was 128.069-384.206 ug/ml （r=0.999 9）. RSDs of precision, stability and reproducibility tests were lower than 0.5%; average recovery was 100.6% （RSD=0.3%, n=9）. A＋1.80S of content uniformity were between 7.3-11.3. CONCLUSIONS： The method is easy to operate with good accuracy and specificity. It can be used for the quality control of Primaquine phosphate tablets.