Study on HPLC and dissolution method for determining the content of Vitamin C Tablets
Objective Establish a high performance liquid chromatography(HPLC)method for determining the content of Vitamin C Tablets,and improve its quality control standards through the newly established method for measuring the dissolution of Vitamin C Tablets.Methods HPLC determination method:The chromatographic column is a Phenanthrene C18 column(250 mm×4.6 mm,5 μm)The mobile phase is 0.1 mol·L-1 potassium dihydrogen phosphate solution(adjusted to pH 2.5 with phosphoric acid)-metha-nol(92∶8),with a flow rate of 0.8 mL·min-1,detection wavelength of 243 nm,column temperature of 30℃,and injection volume of 10 μL;Dissolution determination method:According to the dissolution and release determination method(Appendix 0931,Method 1,Part 4,Pharmacopoeia of the People's Republic of China,2020),1000 mL of 0.1 mol·L-1 hydrochloric acid solu-tion is used as the solvent,and the rotation speed is 50 r·min-1.Samples are taken at 20 minutes.Results Vitamin C ranges from 20 μg·mL-1 to 140 μg·mL-1,there is a good linear relationship with its peak area,y=37487.239x-6860.622(r=0.99996),with an average recovery rate of 100.16%and an RSD value of 0.48%(n=9);The dissolution curves of the five samples were signifi-cantly different in water,0.1 mol·L-1 hydrochloric acid solution,pH 4.0 acetate buffer,and pH 6.8 phosphate buffer each with 1000 mL as the dissolution media.0.1 mol·L-1 hydrochloric acid solution was selected as the dissolution medium for the determination of samples from five enterprises,all of which were completely dissolved and entered the platform within 10 minutes.Conclusion The es-tablished method enhances the accuracy,specificity,and repeatability of detection,and has the advantages of reliability and accuracy,which can effectively control the quality of Vitamin C Tablets.
high performance liquid chromatography(HPLC)Vitamin C Tabletscontentdissolution
NETL
NSTL
万方数据
维普
