Content Determination of Ketoprofen in Ketoprofen Enteric-coated Capsules by Improving HPLC / 中国药房

ABSTRACT

OBJECTIVE:To improve HPLC for content determination of ketoprofen in Ketoprofen enteric-coated capsules. METHODS:HPLC method was adopted. The determination was performed on Chiralpak IC column with mobile phase consisted of n-hexane (0.1% TFA)-isopropanol(9010,V/V)at a flow rate of 0.8 mL/min. The detection wavelength was set at 268 nm,and column temperature was 25 ℃. The sample size was 10 μL. RESULTS:The linear range of ketoprofen were 0.025-0.5 mg/mL(r=0.9998). The limit of quantitation was 1.0 mg/L,and limit of detection was 0.2 mg/L. RSDs of precision,stability and reproduc-ibility tests were lower than 2%;recoveries were 96.36%-100.32%(RSD=1.87%,n=6). CONCLUSIONS:The method is sim-ple,accurate and rapid,and can be used for the content determination of ketoprofen in Ketoprofen enteric-coated capsules.