HPLC测定盐酸丙卡特罗片中有关物质的含量

目的 建立高效液相色谱法测定盐酸丙卡特罗片中的有关物质。方法 采用Waters Symmetry Shield^TM C₁₈（4.6 mm×150 mm，5 μm），以1.0 mmol·L^-1庚烷磺酸钠-甲醇-醋酸（81∶15∶4）为流动相；流速为1.0 mL·min^–1；柱温为35℃；检测波长为254 nm。结果 杂质A、B、C线性相关系数均>0.999，其平均回收率为95.0%~105.0%（n=9），校正因子分别为1.0，0.4，0.5。结论 该法专属性强、简便可靠，适用于盐酸丙卡特罗片有关物质检查，为其质量控制提供检测依据。

Determination of Related Compounds in Procaterol Hydrochloride Tablets by HPLC

OBJECTIVE To establish an HPLC method for the determination of related compounds in procaterol hydrochloride tablets. METHODS The determination method was developed on a Waters Symmetry Shield^TM C₁₈column (4.6 mm×150 mm, 5 μm), with 1.0 mmol·L^-1 sodium heptanesulfonate-methanol-acetic acid(81:15:4) as mobile phase at a flow rate of 1.0 mL·min^-1. The column temperature was maintained at 35℃ and the UV detection wavelength was set at 254 nm. RESULTS The correlation coefficient of impurity A, B and C was all more than 0.999 and the average recovery rates were 95.0%-105.0%(n=9). And the correction factors of impurity A, B, C were 1.0, 0.4, 0.5, respectively. CONCLUSION The method was specific, simple and reproducible for the determination of related compounds in procaterol hydrochloride tablets and provide reliable detection basis for its quality control.