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目的建立盐酸卡替洛尔滴眼液含量测定的高效液相色谱(HPLC)法。方法色谱柱为nucleodur C18柱(150mm×4.6mm,5μm),流动相为10mmol/L磷酸二氢钾溶液(用磷酸调pH=4.0)-乙腈(20∶80),流速为1mL/min,检测波长为252nm,柱温为40℃。结果盐酸卡替洛尔质量浓度在19.85～198.5μg/mL范围内与峰面积线性关系良好(r=0.9998),平均回收率为100.3%,RSD=1.2%(n=9)。结论HPLC法专属性强、灵敏度高、重现性好,结果准确,适用于盐酸卡替洛尔滴眼液的质量控制。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of carteolol hydrochloride eye drops. METHODS The column was a nucleodur C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase of 10 mmol / L potassium dihydrogen phosphate (adjusted to pH 4.0 with phosphoric acid) -acetonitrile (20:80) at a flow rate of 1 mL / The wavelength was 252 nm and the column temperature was 40 ° C. Results The concentration of carteolol hydrochloride in the range of 19.85 ~ 198.5 μg / mL showed a good linear relationship with the peak area (r = 0.9998). The average recovery was 100.3% and RSD was 1.2% (n = 9). Conclusion HPLC method has the characteristics of high specificity, high sensitivity, good reproducibility and accurate results. It is suitable for the quality control of carteolol hydrochloride eye drops.