摘要
目的建立RP-HPLC测定盐酸卡替洛尔有关物质的方法。方法色谱柱为SunFireTMC18(250 mm×4.6mm,5μm),以乙腈为流动相A,以己烷磺酸钠溶液(取己烷磺酸钠2.5g,醋酸铵2g,加水溶解并稀释至1000 ml,用醋酸调节pH 4.0±0.1)为流动相B,梯度洗脱,流速为1.0 ml/min,检测波长为252 nm,柱温为35℃。结果此法能将盐酸卡替洛尔与其有关物质完全分离;杂质H的校正因子为1.08,回收率为102.9%,且杂质H浓度在0.02～10.0μg/ml范围内呈良好线性关系(r=1.0000)。结论此法专属性强,操作简便、准确、快速,灵敏度高,重复性好,可用于盐酸卡替洛尔有关物质检查。
Objective To establish a method for the determination of related substances of carteolol hydrochloride by RP-HPLC. Methods A SunFireTM C18 column was adopted, using acetonitrile as mobile phase A, sodium hexane sulfonate solution(2.5 g of sodium hexane sulfonate and 2 g of ammonium acetate were dissolved in water and diluted to 1000 ml. The pH was adjusted by acetic acid to 4.0 ± 0.1) as mobile phase B. The gradient elution was applied at the flow rate of 1.0 ml/min and the detection wavelength was 252 nm, the column temperature was 35 ℃. Results The method could separate carteolol hydrochloride from its related substances completely. The corresponding correction factor of the related compound H is 1.08, the recovery is 102.9 %, and the related compound H had a good liner relationship within the range of 0.02-10.0 μg/ml(r=1.0000). Conclusion The method is speci?c, simple, accurate, fast,sensitive and repeatable, and can be used to determine the related substances of carteolol hydrochloride.
引文
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