骨肽注射液中苯酚含量的RP-HPLC法测定

RP-HPLC Determination of Phenol in Ossotide Injection

目的:建立高效液相色谱法测定骨肽注射液中苯酚的含量。方法:采用 ZORBAX C_(18)柱(4.6mm×250mm,5μm);流动相为甲醇-水(25:75);流速1.0 mL·mm^(-1);检测波长:270nm;进样量:10μL。结果:方法的线性范围为0.001-1.0mg·mL^(-1)(r=0.9998);检测限为0.2μg·mL^(-1);精密度 RSD 为0.23%(n=7);高、中、低浓度回收率(n=3)分别为98.8%(RSD为0.5%)、99.2%(RSD 为0.2%,)、99.0%(RSD 为0.3%)。结论:本法具有专属、灵敏、快速、准确的特点,可用于骨肽注射液中的苯酚测定。

Objective:To establish an RP-HPLC method to determine phenol in ossotide injection.Method:The HPLC system consisted of C_(18) column(4.6 mm×250 mm,5 μm)with methanol-water(25:75)as mobile phase, detection at 270 nm,the flow rate was 1.0 mL·min^(-1) and the injection volume was 10 μL.Results:The linear range was 0.001-1.0 mg·mL^(-1)(r=0.9998 );the limit of detection was 0.2μg·mL^(-1);the precision RSD was 0.23% (n=7);the recovery (n=3)was 98.8% at a higher concentration (with RSD of 0.5%),99.2% at middle concentration(with RSD of 0.2%) and 99.0% at a lower concentration (with RSD of 0.3%).Conclusion:The method is simple,sensitive,accurate and can be used for the determination of phenol in ossotide injection.