摘要
目的采用高效液相色谱(HPLC)法测定盐酸普鲁卡因及其注射液的含量。方法色谱柱为DiamonsailC18柱(200mm×4.6mm,5μm),以32:68的甲醇-磷酸盐缓冲液(0.05mol/L磷酸二氢钾,0.1%庚烷磺酸钠,用磷酸调pH至3.0)为流动相,检测波长290nm,流速1.0mL/min。结果盐酸普鲁卡因质量浓度在40～2000μg/mL范围内与峰面积线性关系良好,r=0.9999(n=10),平均回收率为100.32%,RSD为0.28%(n=9)。结论HPLC法灵敏、专属、快速方便,可以更好地控制产品质量。
Objective To establish a HPLC method for procaine hydrochloride and procaine hydrochloride injection. Methods To use Diamonsail C18 column with methanol-phosphate buffer solution（0.05 mol/L potassium dihydrogen phosphate, 0. 1% heptane-1-sulfonic acid sodium, adjusting pH 3.0 with phosphoric acid,32：68） as the mobile phase at the flow rate of 1.0 mL/min and the detected wavelength of 290 nm. Results Procaine hydrochloride showed a good linearity in 40-2 000 μg/mL, r=0. 999 9（ n= 10）. The recovery rate was 100.32% with RSD 0.28% （n=9）. Conclusion The new method is sensitive, specific, rapid and simple. It can be used for the quality control of procaine hydrochloride and procaine hydrochloride injection.
出处
《中国药业》
CAS
2009年第24期36-37,共2页
China Pharmaceuticals
