在不同介质中金属铁离子对非洛地平片溶出度影响

Effect of Fe3 + on the Dissolution of Felodipine Tablets in Different Media

考察在不同介质中金属铁离子对非洛地平片溶出度影响。采用HPLC法,色谱柱为ODS Hypersil C18(4.6 mm×250 mm,5μm),流动相为甲醇-乙腈-水(50:15:35),流速为1.0m L·min-1,检测波长为238nm。测定非洛地平片在四种介质(pH1.2盐酸溶液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液及水)中(均含0.3%十二烷基硫酸钠),金属铁离子对其溶出度影响。在pH1.2盐酸溶液介质中产生降解杂质高达13%、在pH4.0醋酸盐缓冲液介质中产生降解杂质1%,pH6.8磷酸盐缓冲液及水未产生降解杂质,三价铁离子在酸性条件,可将非洛地平氧化,导致非洛地平片体外溶出度相关性较差。

Objective:Investigating the effect of Fe3+on the dissolution of felodipine fablets in different media.Method:ODSHypersilC18(250 mm×4.6 mm,5μm)column was used with the mobile phase of a mixture of methanol,acetonitrile and water(50:15:35).The flow rate was 1.0 mL·min-1,and the detection wavelength was 238 nm.The effects of Fe3+concentrations on dissolution of felodipine tablets in vitro,which in pH 1.2 hydrochloric acid solution,pH4.0 acetate buffer solution,pH 6.8 phosphate buffer solution and water(the solutions above contained 0.3%sodium dodecyl sulfate)was investigated under the condition of paddle method at the rotational speed of 50 r·min-1.Results:The degradation of impurities,which in the pH 1.2 hydrochloric acid solution medium up to 13%,and in the pH 4.0 acetate buffer solution is 1%.But there is no degradation of impurities in the pH 6.8 phosphate buffer solution and also in water.Conclusion:Felodipine could be oxidized by Fe 3+in the condition of pH 1.2 hydrochloric acid solution,pH4.0 acetate buffer solution,further cause the poor correlation of the dissolution in vitro of felodipine tablets.