摘要
目的:改进高效液相色谱法测定酮洛芬肠溶胶囊中酮洛芬的含量。方法:采用高效液相色谱法。色谱柱为Chiralpak IC,流动相为正己烷(含0.1%三氟乙酸)-异丙醇(90∶10,V/V),流速为0.8 m L/min,检测波长为268 nm,柱温为25℃,进样量为10μL。结果:酮洛芬检测质量浓度线性范围为0.025~0.5 mg/m L(r=0.999 8),定量限为1.0 mg/L,检测限为0.2 mg/L;精密度、稳定性、重复性试验的RSD<2%;加样回收率为96.36%~100.32%(RSD=1.87%,n=6)。结论:该方法操作简便,准确快速,适用于测定酮洛芬肠溶胶囊中酮洛芬的含量。
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 （90 ： 10, 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= 0.999 8）. The limit of quantitation was 1.0mg/L, and limit of detection was 0.2 mg/L. RSDs of precision, stability and reproducibility tests were lower than 2%; recoveries were 96.36%-100.32% （RSD=1.87% ,n=6）. CONCLUSIONS： The method is simple, accurate and rapid, and can be used for the content determination of ketoprofen in Ketoprofen enteric-coated capsules.
出处
《中国药房》
CAS
北大核心
2017年第18期2579-2581,共3页
China Pharmacy
