复方二氯醋酸二异丙胺氯化钠注射液中二氯醋酸二异丙胺的HPLC测定

Determination of Diisopropylamine Dichloroacetate in Compound Diisopropylamine ichloroacetate and Sodium Chloride Injection by HPLC

目的建立HPLC法测定复方二氯醋酸二异丙胺氯化钠注射液中二氯醋酸二异丙胺的含量。方法用十八烷基硅烷键合硅胶柱,流动相为高氯酸水溶液(0.82 mL高氯酸稀释至1 000 mL,加三乙胺2 mL,磷酸调pH 3.0)-乙腈(97:3),检测波长215 nm,流速1.0 mL/min。结果二氯醋酸二异丙胺在0.48～1.12 mg/mL范围内线性关系良好,平均回收率为100.3%,RSD为0.37%。结论此法简便、准确,可用于复方二氯醋酸二异丙胺氯化钠注射液的质量控制。

Objective To establish a HPLC method for the determination of diisopropylamine dichloroacetate in Compound Diisopropylamine Dichloroacetate and Sodium Chloride Injection. Methods A C18 column was used with the mobile phase of perchloric acid solution（0.82？1000 mL, add 2 mL of triethylamine and regulate pH to 3.0 with phosphoric acid）- acetonitrile （97：3） at the detection wavelength of 215 nm with the flow rate of 1.0 mL/min. Results The calibration curve was linear in the range of 0.48-1.12 mg/mL. The average recovery was 100.3% with RSD of 0.37%. Conclusion The method is simple and accurate and it can be used for the quality control of Compound Diisopropylamine Dichloroacetate and Sodium Chloride Injection.