高效液相色谱法同时测定复方布洛芬缓释胶囊中布洛芬和精氨酸的含量

Simultaneous determination content of ibuprofen and arginine in Compound Ibuprofen Sustained Release Capsules by HPLC

目的 高效液相色谱法同时测定复方布洛芬缓释胶囊中布洛芬和精氨酸的含量.方法 采用Diamonsil TM C18柱（250mm×4.6mm,5μm）,以乙腈：0.1mol·mL-1磷酸二氢钾溶液（磷酸调pH 3.0）为流动相,梯度洗脱（0→8min→10min→12min,15%→60%→70%→15%）,检测波长：0～15min,357nm,15min切换到263nm,流速为1mL·min-1,柱温为25℃.结果 精氨酸线性回归方程为y=61655x＋63114,其在1.64～164ng（r=0.9996）范围内呈良好的线性关系,平均回收率为100.36%（RSD=0.70%）.布洛芬线性回归方程为：y=533084x-355126,其在2.06～206ng（r=0.9994）范围内呈良好的线性关系,平均回收率为98.67%（RSD=0.57%）.结论 通过波长切换的高效液相色谱法测定复方布洛芬缓释胶囊中布洛芬和精氨酸的含量快速,测量结果准确,为复方布洛芬缓释胶囊的质量标准的建立与完善提供科学依据,并指导临床合理用药.

OBJECTIVE To develop the method to simultaneously determinate content of Ibuprofen and Argi- nine in compound ibuprofen sustained release capsule by high performance liquid chromatography. METHODS Di- amonsil TM C18 column （250mm ℃ 4.6mm, 51xm） was used, with acetonitrile and 0. 1 mol · mL- 1 of potassium di- hydrogen phosphate solution （adjust pH to 3.0 by phosphate） as mobile phase, gradient elution （0,8min, 10min, 12min,acetonitrile for t5% ,60% ,70% ,60% ） ,detection wavelength ：0 ~ 15 rain for 357 nm, at 15 min wavelength was switched to 263 nm,flow rate was 1mL ·min-1 ,column temperature was 25℃. RESULTS Arginine linear re- gression equation was y = 61655x ＋ 63114. it had good linear relationship within the scope for 1.64 ~ 164ng （r = 0. 9996） ,the average recovery, was 100. 36% （ RSD = 0. 70% ） . Ibuprofen linear regression equation was： y = 533084x -355126, it had good linear relationship for 2. 06 ~ 206ng （r = 0. 9994）, the average recovery was 98.67% （ RSD = 0. 57% ）. CONCLUSION The method is fast and accurate. It provide a scientific basis for the establish- ment and perfection of quality standards of compound ibuprofen sustained-release capsules, which can guide clinical rational drug use.