Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

OBJECTIVE:To establish a method for simultaneous determination of 4 residual organic solvents such as ethanol,dichloromethane,isopropanol and ethyl acetate in lacidipine raw material.METHODS:GC method was adopted.The determination was performed on DB-624 capillary column at the rate of 2.0 mL/min using nitrogen gas as carrier and FID as the detector by temperature programming.The temperature of detector was set at 250 ℃.Carries gas was nitrogen.The split ratio was 10 ∶ 1.The sample size was 10 μL.RESULTS:The linear ranges of ethanol,dichloromethane,isopropanol and ethyl acetate were 0.259 5-2.076 mg/mL (r=0.999 6),0.055 3-0.316 mg/mL (r=0.999 2),0.342 3-1.956 mg/mL (r=0.999 5),0.370 6-2.118 mg/mL(r=0.999 4),respectively.The limits of quantification were 2.96,2.24,4.4,4.44 μg/mL,and the detection limits were 0.887,0.672,1.3,1.32 μg/ mL,respectively.RSDs of precision,stability and reproducibility tests were all lower than 4.0％.The recoveries were 95.00％-101.17％ (RSD=2.19％,n=9),96.22％-104.53％ (RSD=3.27％,n=9),96.20％-104.90％ (RSD=2.41％,n=9),95.60 ％-104.48 ％ (RSD=2.85 ％,n=9).CONCLUSIONS:The method is simple,sensitive and reliable,and is suitable for simultaneous determination of 4 residual organic solvents in lacidipine raw material.