摘要
目的:建立高效液相色谱法测定盐酸巴尼地平的含量及其相关物质。方法:采用Phenomenex-Gemini C18(5μm,4.6mm×250 mm)色谱柱,以甲醇-0.005 mol·L-1KH2PO4(50∶50,pH 3.0)为流动相,检测波长为236 nm,流速为1.0 mL·min-1,柱温为室温。结果:盐酸巴尼地平主要成分与其相关物质峰完全分离,在6～14μg·mL-1浓度范围内呈良好线性关系,平均回收率99.6%,RSD=0.5%(n=5)。结论:该方法专属性好,精密度、准确度符合要求,方法可靠,可用于盐酸巴尼地平的含量及其相关物质的测定。
Objective ：To develop an HPLC method for the determination of barnidipine hydrochloride and its related substances. Methods：The determination was performed on an Phenomenex -Gemini C18 （5 μm,4.6 mm ×250 mm） column with methanol-0. 005 mol·L^-1KH2PO4 （50： 50, pH 3.0） as the mobile phase. The flow rate was 1.0 mL·min^-1, the detection was set at 236 nm and the column temperature was maintained at room temperature. Results：Barnidipine and its related substance were completely separated. The calibration curve was linear in the range of 6 - 14 g · mL^-1, the average recovery was 99.6%, RSD = 0.5% （ n = 5 ）. Conclusion： The method is proved to be specific, accurate and reproducible. The proposed HPLC method can be used for the determination of barnidipine hydrochloride and its related substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第2期320-322,共3页
Chinese Journal of Pharmaceutical Analysis
