Simultaneous Determination of 5 Kinds of Acid and Alkaline Components in Anti-cold Compound Preparation by HPLC Based on Auto·Blend Plus Technology / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for simultaneous contents determination of 5 kinds of acid and alkaline componentsin anti-cold compound preparation. METHODS:HPLC method was adopted. The workstation was Auto·Blend Plus software of ACQUITY Arc system. The determination was performed on Discovery?HS F5-5 column with mobile phase consisted of acid mixture-base mixture-methanol-0.3% triethylamine (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelengths were set at 270 nm (acetaminophen,salicylamide,chlorphenamine maleate,triprolidine hydrochloride) and 299 nm (aspirin). The column temperature was 35 ℃,the sample size was 20 μ L. RESULTS:The linear ranges of acetaminophen, salicylamide,acetylsalicylic acid,chlorphenamine maleate,triprolidine hydrochloride were 26-411 μ g/mL(r＝0.999 6),16-254 μg/mL(r＝0.999 8),16-748 μg/mL(r＝0.998 1),35-565 μg/mL(r＝0.999 8)and 25-404 μg/mL(r＝0.999 7),respectively. LOQ were 3.6,3.1,4.0,9.6,6.3 μ g/mL;LOD were 1.9,1.3,1.4,2.9,2.3 μ g/mL,respectively. RSDs of intermediate precision, stability and reproducibility tests were all lower than 2%. Average recoveries were 100.0%-102.0%(RSD＝0.59%,n＝9), 95.2%-101.0%(RSD＝1.55%,n＝9),96.2%-99.9%(RSD＝1.24%,n＝9),96.2%-101.5%(RSD＝1.57%,n＝9),96.3%-98.9%(RSD＝0.83%,n＝9),respectively. RSDs of durability tests were lower than 3%. CONCLUSIONS:The method is simple, accurate,precise,stable,reproducible and durable,and can be used for simultaneous contents determination of 5 kinds of acid and alkaline components in anti-cold compound preparation.