高效液相色谱法测定氯酚伪麻缓释片中3组分的含量

目的 :建立以高效液相色谱法测定氯酚伪麻缓释片中对乙酰氨基酚 (Par)、氯雷他定 (Lor)和盐酸伪麻黄碱 (Pse)含量的方法。方法 :以Kromasil-C18(250mm×4 6mm ,5μm)为色谱柱 ,用甲醇 -醋酸钠 (200∶1000)为流动相测定Par ,检测波长为243nm ;用醋酸 -甲醇 -1 %十二烷基硫酸钠 (0 1∶70∶30)为流动相测定Lor、Pse ,检测波长为257nm。结果 :标准曲线的线性范围Par为13 79～55 18μg/ml(r=0 9999) ,Lor、Pse分别为0 013～0 105、0 30～2 37mg/ml(r=0 9999) ,平均回收率依次为99 89 % (RSD=0 43% )、99 69 % (RSD=0 20 % )、99 57 % (RSD=0 10 % )。结论 :本法精密度好 ,测定结果准确、可靠 ,适用于该复方制剂的质量检验分析

Studies on Quantitative Determination of Ingredients in Loratadine Paracetamol Pseudoephedrine Sulfate Sustained- release Tablets by RP- HPLC

OBJECTIVE:To establish a HPLC method for the quantitative determination of loratadine(Lor),paracetamol(Par)and pseudoephedrine sulfate(Pse)in loratadine paracetamol pseudoephedrine sulfate sustained-release tablets(LPPST). METHODS:The HPLC method was carried out on Kromasil-C 18 column(250mm×4.6mm,5μm).The mobile phase consisted of a mixture of methanol-sodium acetate(0.82g in1000ml)(2000∶1000)for paracetamol with detection at243nm.The moˉbile phase consisted of a mixture of acetic acid-methanol-1%(V/V)sodium lauryl sulfate(0.1∶70∶30)for loratadine and pseudoephedrine sulfate with detection at257nm.RESULTS:The calibration curve was linear in the range of13.79～55.18μg/ml for paracetamol(r=0.9999),0.013～0.105mg/ml for loratadine(r=0.9999),0.30～2.37mg/ml for pseudoephedrine sulˉfate(r=0.9999).The average recoveries were99.89%(RSD=0.43%),99.69%(RSD=0.20%)and99.57%(RSD=0.10%)for three above-mentioned components respectively(n=6).CONCLUSION:This method is accurate and reliable for the quality control of this compound preparation.