HPLC同时测定复方双氯芬酸钠注射液中两组分的含量

Simultaneous determination of two components in compound diclofenac sodium injection by HPLC

目的:建立HPLC测定复方双氯芬酸钠注射液中两组分含量的方法。方法:以Kromasil ODS(250 mm×4.6 mm,5μm)为色谱柱,流动相为ψ(甲醇:乙酸盐缓冲液,pH4.6)=70:30,流速为1.0 mL/min,检测波长为245 nm,柱温为30℃,进样量为20 μL,外标法定量。结果:双氯芬酸钠和盐酸利多个因的线性范围分别为18.8～188.0μg/mL(r=0.9999)和5.3～53.0μg/mL(r=0.9999),平均回收率分别为100.3％(RSD=0.77％)和99.23％(RSD=0.59％)。结论:本方法结果准确,重现性好,简便快速,可作为该制剂的含量测定方法。

Objective:To establish a HPLC method for the simultaneous determination of diclofenac sodium and lidocaine hydrocride in injection. Methods:The analytical column is Kromasil ODS (250 mm ×4.6 mm,5μm) , the mobile phase consisted of μ(methanol : buffer containing acetate,pH4. 6) = 70 : 30, flow rate was 1. 0 mL/min, detection was done at 245 nm, column temperature was 30℃ , 20 μL sample was used, with external standard method to fix quantify. Results;The calibration curves for diclofenac sodium and lidocaine hydrochloride were linear in the range of 18. 8 - 188.0μg/mL(r =0.9999) and 5. 3 -53.0μg/mL(r =0. 9999) respectively. The average recovery rates of diclofenac sodium and lidocaine hydrochloride were 100. 3% ( RSD = 0. 77% ) and 99. 23% (RSD = 0. 59% ) respectively. Conclution ;This method is simple, accurate with good repeatability.