HPLC测定盐酸异丙嗪糖浆中盐酸异丙嗪含量

Determination of Promethazine Hydrochloride in Promethazine Hydrochloride Syrup by HPLC

目的建立高效液相色谱法测定盐酸异丙嗪糖浆中盐酸异丙嗪的含量。方法以NUCLEODUR100-5C-18cc（150mm×4．6mm，5μm）为色谱柱，0.02mol·L^-1磷酸二氢钾缓冲盐溶液（取磷酸二氢钾2．72g加水700mL溶解，用磷酸调节pH=3．0．加水至1000mL）．乙腈-甲醇（60：17：23）为流动相，流速0．8mL·min^-1，检测波长为249nm；柱温为30℃。结果盐酸异丙嗪在5．445-98．01μg·mL^-1浓度范围内线性关系良好（r=0．99993）；方法精密度RSD=0．78％（n=6）；其高、中、低三个量的平均回收率为99．88％，99．91％，100．2％，RSD分别为0．31％，0．21％，0．46％。结论本方法准确、可靠，适用于盐酸异丙嗪糖浆的含量测定。

OBJECTIVE To establish a HPLC method for determining the content of promethazine hydroehloride in promethazine hydrochloride syrup. METHODS The determination of promethazine hydrochloride in promethazine hydrochloride syrup was carried on a column of NUCLEODUR100-SC18cc （ 150 mm × 4.6 mm ,5 μm） by HPLC ,with the mixture of 0.02 mol · L ^-1 potassium dihydrogen phosphate buffer solution（2.72 g potassium dihydrogen phosphate was dissolved in 700 mL of water,adjusted to pH = 3.0 by H3PO4and diluted with water to 1 000 mL）-acetonitrile- methanol （60： 17： 23） as the mobile phase; The flow rate was 0.8 mL · min^-1 ;The detection wavelength was 249nm; The column temperature was 30 ℃. RESULTS The linear range of determination by HPLC was 5. 445 - 98.01 μg · mL ^- 1 （ r = 0.999 93 ）. The precision （RSD） was 0.78% （ n = 6）. The average recoveries was 99.88% ,99.91% , 100.2% with corresponding RSD of 0.31% ,0.21% ,0.46% ,respectively. CONCLUSION The method is accurate and reliable, which is suitable for the determination of the promethazine hydrochloride in promethazine hydrochloride syrup.