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

ABSTRACT

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,5?m).The mobile phase consisted of a mixture of methanol-sodium acetate(0.82g in1000ml)(2000∶1000)for paracetamol with detection at243nm.The mo?bile 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 of13.79～55.18?g/ml for paracetamol(r=0.9999),0.013～0.105mg/ml for loratadine(r=0.9999),0.30～2.37mg/ml for pseudoephedrine sul?fate(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.