摘要:
目的 建立HPLC法测定麻杏口服液中盐酸麻黄碱及盐酸伪麻黄碱的含量。 方法 采用Phenomenex Hydro-RP (250 mm×4.6 mm,4 μm)色谱柱,以乙腈(A)-0.1%磷酸溶液(含0.1%三乙胺)(B)为流动相,梯度洗脱(0~20 min,3%→10% A),流速:1.0 ml/min,检测波长:210 nm,进样量:20 μl。 结果 盐酸麻黄碱在0.99~39.6 μg/ml范围内线性关系良好,r=0.999 9, 平均回收率为101.5%,RSD为1.77%(n=6);盐酸伪麻黄碱在1.09~43.6 μg/ml范围内线性关系良好,r= 0.999 9,平均回收率为100.8%, RSD为 1.96%(n=6)。 结论 本法简便、可靠、准确,可用于该制剂的质量控制。
Abstract:
Objective To establish an HPLC method for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Maxing oral solution. Methods Phenomenex Hydro-RP (250 mm×4.6 mm, 4 μm) was adopted. Acetonitnile (A) and 0.1% phosphonic acid solution (0.1% triethanolamine solution)(B) was used as gradient mobile phase(0-20 min, 3%→10% A)at flow rate was 1.0 ml/min and the program of UV gradient absorbance detection was 210 nm. The sample volume was 20 μl. Results A good linearity was obtained over the concentration range of 0.99-39.6 μg/ml for ephedrine hydrochloride (r=0.999 9) and 1.09-43.6 μg/ml for pseudoephedrine hydrochloride (r=0.999 9). The average recovery of ephedrine hydrochloride was 101.5% with RSD of 1.77% (n=6), and the average recovery of pseudoephedrine hydrochloride was 100.8% with RSD of 1.96% (n=6). Conclusion This method was simple,accurate and quick,which could be used for determination and quality control of Maxing oral solution with good selectivity and repeatability.
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