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目的:建立高效液相色谱法,测定盐酸异丙嗪注射液的含量和有关物质。方法:采用C_(18)柱,以0.05 mol·L~(-1)磷酸二氢铵(用磷酸调节pH至3.2)-乙腈(70:30)为流动相,流速1.0 mL·min~(-1),检测波长249 nm。结果:盐酸异丙嗪浓度在10.13～121.58μg·mL~(-1)范围内呈良好的线性关系,r=0.9995;平均回收率为100.3%,RSD=0.33%(n=6);有关物质各杂质与主峰之间的分离度良好。检测限和定量限分别为0.4 ng和1.6 ng。结论:本法简便、准确,专属性好,灵敏度高。
Objective: To establish a HPLC method for the determination of promethazine hydrochloride injection and its related substances. Methods: The mobile phase consisted of 1.0 mL · min ~ (-1) C_ (18) column with 0.05 mol·L -1 ammonium dihydrogen phosphate (adjusted to pH 3.2 with phosphoric acid) and acetonitrile (70:30) 1), detection wavelength 249 nm. Results: Promethazine hydrochloride had a good linearity in the range of 10.13-121.50 μg · mL -1, r = 0.9995. The average recovery was 100.3%, RSD was 0.33% (n = 6) The degree of separation between each impurity and the main peak is good. The limits of detection and limit of quantification were 0.4 ng and 1.6 ng, respectively. Conclusion: This method is simple, accurate, specific and sensitive.