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目的:建立HPLC法测定消炎止敏丸中马来酸氯苯那敏中的含量。方法:色谱柱:Phenomenex C_(18) Gemini(250 mm×4.6mm,5μm),流动相:甲醇-0.5%磷酸溶液(65:35),柱温:室温,流速:1.0ml·min~(-1),检测波长:225nm。结果:马来酸氯苯那敏进样量0.206～1.030μg范围内与峰面积呈良好线性关系(r=0.999 6),平均回收率为99.80%,RSD=1.1%(n=5)。结论:方法简便,结果准确,可作为本品质量控制的有效方法。
Objective: To establish an HPLC method for the determination of chlorphenamine maleate in Xiaoyanzhimu Pill. METHODS: Phenomenex C_ (18) Gemini (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of methanol and 0.5% phosphoric acid solution (65:35). The column temperature was at room temperature and the flow rate was 1.0 ml · min ~ 1), detection wavelength: 225nm. Results: The calibration curve of chlorphenamine maleate showed a good linearity (r = 0.999 6) within the range of 0.206 ~ 1.030 μg with an average recovery of 99.80% and a RSD of 1.1% (n = 5). Conclusion: The method is simple and accurate. It can be used as an effective method for the quality control of this product.