Detection of substances in compound fluocinonide tincture
Objective:Establishing a method to detect the determination of substances in compound fluocinonide tincture.Method:The column was Ultimate LP-C18 (250∗4.6mm,5μm),the mobile phase was 55％aqueous methanol,the flow rate is 1.0 mL/min,the detection wavelengths were 235nm and 245nm,the column temperature was 30℃,and the injection volume was 10μL.Result:In the proprietary test,the separation between the known impurities and the main peak and between the impurity and impurity peaks was greater than 2.0,and the peaks were well separated from each other;In the system suitability test,the peak area RSD value was 1.42％ and the retention time RSD value was 0.84％;In the solution stability test,the impurity extreme change in the solution of Fludrocortisone acetate API was less than 0.05％ in 24h;The limit of quantification (LOQ)and limit of detection (LOD)tests showed that the LOQ was 0.032％ of test article (0.4mg/mL);In the linearity and range test,fluocinonide acetate showed good linearity in the range of 0.30μg/mL to 6.04μg/mL with the equation:y=16807x+3692.8;In the accuracy test,the recoveries of fluoride ease ranged from 80.0％ to 120.0％ with an average recovery is 100.5％ and RSD is 1.5％;In the durability test,single and total impurities were measured to vary between 0.1 per cent after changing conditions.Conclusion:The method is exclusive,sensitive and accurate,which is an effective way to detect the related substances in compound fluocinonide tincture.
compound fluocinonide tincturedetection of substancesHigh Performance Liquid Chromatograph
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NSTL
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