HPLC法同时测定布洛肾素那敏片中三组分的含量

HPLC Determination of Three Components in Allergy and Congestion Relief

目的建立HPLC法同时测定布洛肾素那敏片中布洛芬、去氧肾上腺素和氯苯那敏的含量。方法采用Ultimate C18色谱柱(250mm×4.6mm,5μm),以0.1%辛烷磺酸钠溶液(调节p H值至3.0)为流动相A,乙腈-甲醇=1:1为流动相B,梯度洗脱,流速为1.0mL/min,柱温为30℃,检测波长为262nm(布洛芬和氯苯那敏)和274nm(去氧肾上腺素),进样量20μL。结果当布洛芬的质量浓度在0.10~4.00mg/mL(r=0.9998)、去氧肾上腺素的质量浓度在5.32~212.96μg/mL(r=0.9999)、氯苯那敏的质量浓度2.00~80.13μg/mL(r=0.9999)范围内时,与峰面积线性关系良好;布洛芬、去氧肾上腺素、氯苯那敏的加样回收率分别为99.7%、100.0%、98.4%,RSD分别为1.2%、1.5%、1.3%(n=6);样品溶液在12h内稳定。结论本方法简便、快速,可同时有效测定布洛肾素那敏片中布洛芬、去氧肾上腺素和氯苯那敏的含量。

Objective:To establish a method for simultaneous determination of ibuprofen,phenylephrine and chlorphenamine by HPLC.Methods:At Ultimate C18 Column(4.6 mm×250 mm,5 μm) was uesed.Gradient elution was used with 0.1% octanesulfonic acid sodium(pH was adjusted to 3.0 with phosphoric acid) as mobile phase A and acetonitrile-methanol=1:1 as mobile phase B,The flow rate is 1.0 mL/min,the column temperature is 30℃.Detection wavelength was set at 262 nm(detecting ibuprofen and chlorphenamine) and 274 nm(detecting phenylephrine).Results:Better linearities and good correlation coefficients were obtained:the concentration ranges of ibuprofen,phenylephrine hydrochloride acid and chlorphenamine maleate were over 5.32μg/ml~212.96μg/ml(r=0.9999),5.32 μg/ml~212.96μg/ml(r=0.9999),and 2.00μg/ml~80.13μg/ml(r=0.9999),respectively.The recoveries of ibuprofen,phenylephrine and chlorphenamine were 99.7%,100.0%,98.4% and RSD:1.2%,1.5%,1.3%(n=6).The sample solution was stable within 12 h.Conclusion:The method is simple,rapid and effective for the determination of ibuprofen,phenylephrine and chlorphenamine in allergy and congestion relief.