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目的:建立HPLC法测定愈创维林那敏片中愈创甘油醚、枸橼酸喷托维林和马来酸氯苯那敏含量的方法。方法:色谱柱为Inertsil ODS-3(250mm×4.6mm,5μm),流动相为1%三乙胺溶液(用磷酸调节pH至3.0)-甲醇(45:55),检测波长215nm,流速1.0ml·min~(-1),柱温35℃,进样量20μl。结果:愈创甘油醚、枸橼酸喷托维林和马来酸氯苯那敏的线性范围分别为18.2～42.5μg·ml~(-1)(r=1.000 0)、89.5～208.9μg·ml~(-1)(r=0.9999)和17.8～41.4μg·ml~(-1)(r=0.9999),平均回收率分别为100.8%(RSD=1.3%),100.6%(RSD=0.5%)和101.7%(RSD=1.5%)。结论:本方法简便、准确、专属性强,可用于愈创维林那敏片的质量控制。
OBJECTIVE: To establish a HPLC method for the determination of guaifenesin, pentobarbitone citrate and chlorpheniramine maleate in guativuolinamin tablets. Methods: The chromatographic column was Inertsil ODS-3 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 1% triethylamine solution (adjusted to pH 3.0 with phosphoric acid) and methanol (45:55) · Min ~ (-1), column temperature 35 ℃, injection volume 20μl. Results: The linear ranges of guaifenesin, pentoxyverine citrate and chlorpheniramine maleate were 18.2-42.5μg · ml -1 (r = 1.000 0) and 89.5-208.9μg · The average recoveries were 100.8% (RSD = 1.3%), 100.6% (RSD = 0.5%) and the average recoveries were 100.0% (r = 0.9999) and 17.8 ~ 41.4 μg · ml ~ (-1) ) And 101.7% (RSD = 1.5%). Conclusion: The method is simple, accurate and specific and can be used for the quality control of Vitalin tablets.