反相高效液相色谱法测定布南色林原料的含量及有关物质

摘要

目的 建立测定布南色林及其有关物质含量的反相高效液相色谱法.方法 色谱柱为Waters Xterra RP18柱(250 mm×4.6mm,5μm),流动相为乙腈-甲醇-25 mmol/L的磷酸二氢钠溶液(内含25mmol/L庚烷磺酸钠,用磷酸调pH至3.0,35∶30∶35),检测波长为243 nm,流速为1 mL/min,柱温为30℃,进样量为10μL.结果 布南色林检测质量浓度的线性范围为1.022～10.22μg/mL(r=0.999 4),平均回收率为100.14%(RSD=0.82%).结论 所用方法简便、准确、专属性强,可用于该原料的质量控制.%Objective To establish an RP - HPLC method for the determination of blonanserin and its related substances. Methods Tie method was performed on a Waters Xterra RP18 column(250 mm ×4. 6 mm,5 μm) using acetonitrile - methanol - 25 mmol NaH2PO4 (containing 25 mmol sodium 1 -heptanesul - fonate,pH =3. 0 adjusted by phosphate acid,35 ∶ 30 ∶ 35) as the mobile phase at a flow rate of 1 mL/min. The detection wavelength was at 243 nm. The column temperature was 30 ℃ and the sample size was 10 μL. Results The linear range of blonanserin was 1. 022 - 10. 22 μg/mL( r = 0. 999 4) , the average recovery was 100. 14％ , RSD = 0. 82％ ( n =9). Conclusion The method is simple,accurate,special and can be used for the quality control of blonanserin.