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8405138 
Journal Article 
HPLC法测定盐酸卡替洛尔滴眼液有关物质 
Li, ZY; Liu, Y; Liu, W 
2020 
Chinese Journal of New Drugs Co. Ltd. 
29 
11 
1297-1300 
Chinese 
Objective: To establish a method for the determination of related substances in carteolol hydrochloride eye drops by high performance liquid chromatography (HPLC) and improve the quality standards of the eye drops. Methods: HPLC method was developed with ODS C18 (250 mm×4.6 mm, 5 μm) as the chromatographic column and eluted at a flow rate of 1.0 mL•min-1 with mobile phase consisting of methanol-acetonitrile-2.82 g•L-1 sodium hexane sulfonate solution(10:200:790). The column temperature, detection wavelength and the injection volume were set at 30 ℃, 252 nm and 20 μL, respectively. Results: Carteolol hydrochloride and impurity H were completely separated. The impurity H showed a good linear relationship with the peak area of the chromatogram in the range of 0.02~20.0 μg•mL-1 (r=1.000 0). The correction factor of impurity H was 0.62. The acceleration and long-term stability tests of carteolol hydrochloride eye drops were carried out using the developed method. All the results were within the qualified range and no significant change was observed. Conclusion: The method is reliable, effective, high sensitive, fast detectable and can be used to detect related substances of carteolol hydrochloride eye drops. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved. 
Carteolol hydrochloride; HPLC; Quality control; Quality standard; Related substances