Determination of 5 related substances in propofol medium/long chain fat emulsion injection by HPLC
Objective In order to improve the quality control level of propofol medium/long chain fat emulsion injection,a high performance liquid chromatography(HPLC)method was established for the determination of related substances in propofol medium/long chain fat emulsion injection.Methods Using InertsilTM ODS-3V(250 mm×4.6 mm,5 μm)as the chromatographic column with phosphate buffer(pH 3.0)as Mobile phase A,acetonitrile as mobile phase B,carry out gradient elution.The column temperature was set at 40℃and the flow rate was 1.5 mL·min-1.The UV detection was set as 275 nm,254 nm and sample injection volume was 10 μL.Results Under the chromatographic conditions,the separation degree of the five related substances meets the requirements;the impurities and degradation products of propofol can be well separated under the conditions of acid,alkali,oxidation,high temperature,high temperature oxidation and light degradation;propofol and each impurity has a good linear relationship in the concentration range of 0.185 2-2.063 7 μg·mL-1(correlation coefficient r>0.999);the RSD of each impurity and total impurity content of 12 repeatable samples were less than 5.5%and the recovery rate is within 92%-108%(RSD≤5%,n=9);The test sample was investigated under the conditions of slight changes in column temperature,flow rate,mobile phase ratio and pH.The changes of all parameters had no effect on the results,and the durability was good.Conclusion The method is simple and specific,and can accurately determine the content of five related substances of impurities in propofol medium/long-chain fat emulsion injection.
万方数据
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