二盐酸奎宁注射液质量标准的研究

目的建立二盐酸奎宁注射液含量测定和有关物资的测定方法。方法采用高效液相色谱法现对二盐酸奎宁注射液的含量测定,增加有关物资测定方法,采用反相色谱柱为KromasilC18（5μm,200mm×4.6mm）的高效液相色谱法进行分离,流动相为甲醇-乙腈-水（150：100：750）[1000ml溶液,加三乙胺3ml,用磷酸调pH至2.5,摇匀]流速为1.00ml/min,检测波长250nm。结果二盐酸奎宁在5.0～50.0μg/ml范围内线性关系良好,相关系数r=0.9998（n=5）,平均回收率99.68%。有关物资杂质峰与主成分峰均能达到有效分离。结论 HPLC法可以适用于二盐酸奎宁注射液的含量和有关物资测定,并且操作简单,结果准确可靠。

Research of the quality standard of quinine dihydrochloride injection

Objective To establish a HPLC method for the content determination and related substance of quinine dihydrochloride injection. Methods A HPLC method was used with Kromasil C18（5 μm,200 mm × 4. 6 mm）;The mobile phase was methanol-acetonitrile-water[1000 ml of mobile phase,add 3 ml of trithylamine and adjust pH to 2. 5 by phosphoric acid]（150：100：750） ,flow rate was 1. 00 ml/min;and the detective wavelength was 250 nm. Results The calibration curve was linear within the range of 5. 0 ～ 50. 0 μg/ml,r = 0. 9998（n =5） . The average recovery was 99. 68%. The peak of impurity of related substance and the peak of major constituent were completely separated. Conclusion The method can be used in the content determination and related substance of quinine dihydrochloride injection. It is rapid,accurate and reliable.