摘要
目的建立测定维生素C片含量的高效液相色谱(high performance liquid chromatography,HPLC)法,并通过新建的维生素C片溶出度的测定方法提高其质量控制标准。方法HPLC测定法:色谱柱为菲罗门C_(18)柱(250 mm×4.6 mm,5μm),流动相为0.1 mol·L^(-1)磷酸二氢钾溶液(用磷酸调节pH值至2.5)-甲醇(92∶8),流速为0.8 mL·min^(−1),检测波长为243 nm,柱温为30℃,进样量为10μL;溶出度测定法:按照溶出度与释放度测定法(《中华人民共和国药典》2020年版四部附录0931第一法),以0.1 mol·L^(-1)盐酸溶液1000 mL为溶剂,转速为50 r·min^(−1),20 min时取样。结果维生素C在20~140μg·m L^(-1)范围内与其峰面积线性关系良好,y=37487.239x−6860.622(r=0.99996),平均回收率为100.16%,RSD值为0.48%(n=9);其在水、0.1 mol·L^(-1)盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液各1000 mL的溶出介质中的溶出曲线差异明显,选择0.1 mol·L^(-1)盐酸溶液为溶出介质对5个企业的样品进行测定,均在10 min全部溶出并进入平台。结论所建立的方法使检测的准确性更高、专属性更强、重复性更好,具有可信、精准的优势,能更有效地对维生素C片进行质量控制。
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 C_(18) column(250 mm×4.6 mm,5μm)The mobile phase is 0.1 mol·L^(-1) potassium dihydrogen phosphate solution(adjusted to pH 2.5 with phosphoric acid)-methanol(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 10μL;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 solution 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 20μg·mL^(-1) to 140μg·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 significantly 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 established 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.
作者
朱清丽
谭艳萍
李宁
涂蓉荣
ZHU Qingli;TAN Yanping;LI Ning;TU Rongrong(Ankang Institute for Food and Drug Control,Ankang 725000,China)
出处
《西北药学杂志》
2024年第1期44-48,共5页
Northwest Pharmaceutical Journal
